Trial Outcomes & Findings for A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies (NCT NCT00162123)

NCT ID: NCT00162123

Last Updated: 2016-07-27

Results Overview

An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

248 participants

Primary outcome timeframe

Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.

Results posted on

2016-07-27

Participant Flow

Of 248 enrolled, 6 failed screening; 28 from study CA184-004 (NCT00261365), 42 from CA184-007 (NCT00135408), 67 from CA184-008 (NCT00289627), and 103 from CA184-022 (NCT00289640) entered CA184-025 (NCT00162123). Of enrollees, 2 from study MDX010-08 (NCT00050102) and 6 from MDX010-15 (NCT00729950) entered maintenance as Tumor Assessment Only.

Participant milestones

Participant milestones
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, Other Dosage
Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
Extended Maintenance Only: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance Only: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance Only: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Overall Study
STARTED
53
34
24
11
45
13
4
58
Overall Study
Received Treatment
53
34
24
11
33
12
4
0
Overall Study
COMPLETED
9
5
3
3
14
4
0
0
Overall Study
NOT COMPLETED
44
29
21
8
31
9
4
58

Reasons for withdrawal

Reasons for withdrawal
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, Other Dosage
Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
Extended Maintenance Only: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance Only: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance Only: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Overall Study
Disease progression
27
19
10
4
8
3
1
0
Overall Study
Study drug toxicity
6
1
5
0
4
1
1
0
Overall Study
Death
3
3
1
1
1
1
0
0
Overall Study
Withdrawal by Subject
2
0
2
1
1
2
1
0
Overall Study
Deterioration without progression
2
2
3
0
1
0
0
0
Overall Study
Adverse Event
1
2
0
2
1
0
0
0
Overall Study
Not specified (before treatment)
2
0
0
0
12
1
0
0
Overall Study
Not specified (after start of treatment)
0
0
0
0
3
0
0
0
Overall Study
Physician Decision
1
2
0
0
0
1
1
0
Overall Study
Tumor assessment only (not treated)
0
0
0
0
0
0
0
1
Overall Study
Follow-up only (not treated or assessed)
0
0
0
0
0
0
0
57

Baseline Characteristics

A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
n=53 Participants
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
n=34 Participants
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
n=24 Participants
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, Other Dosage
n=11 Participants
Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
Extended Maintenance: Ipilimumab, 10 mg/kg
n=45 Participants
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 3 mg/kg
n=13 Participants
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 0.3 mg/kg
n=4 Participants
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
n=58 Participants
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Total
n=242 Participants
Total of all reporting groups
Age, Continuous
55.4 Years
STANDARD_DEVIATION 11.7 • n=5 Participants
58.8 Years
STANDARD_DEVIATION 9.9 • n=7 Participants
56.0 Years
STANDARD_DEVIATION 15.3 • n=5 Participants
57.8 Years
STANDARD_DEVIATION 13.7 • n=4 Participants
60.5 Years
STANDARD_DEVIATION 12.42 • n=21 Participants
59.0 Years
STANDARD_DEVIATION 16.65 • n=10 Participants
65.5 Years
STANDARD_DEVIATION 4.80 • n=115 Participants
56.3 Years
STANDARD_DEVIATION 12.96 • n=6 Participants
57.7 Years
STANDARD_DEVIATION 12.55 • n=6 Participants
Sex: Female, Male
Female
21 Participants
n=5 Participants
11 Participants
n=7 Participants
4 Participants
n=5 Participants
1 Participants
n=4 Participants
20 Participants
n=21 Participants
5 Participants
n=10 Participants
1 Participants
n=115 Participants
22 Participants
n=6 Participants
85 Participants
n=6 Participants
Sex: Female, Male
Male
32 Participants
n=5 Participants
23 Participants
n=7 Participants
20 Participants
n=5 Participants
10 Participants
n=4 Participants
25 Participants
n=21 Participants
8 Participants
n=10 Participants
3 Participants
n=115 Participants
36 Participants
n=6 Participants
157 Participants
n=6 Participants
Race/Ethnicity, Customized
Asian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
1 Participants
n=6 Participants
2 Participants
n=6 Participants
Race/Ethnicity, Customized
Black or African American
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
Race/Ethnicity, Customized
White
51 Participants
n=5 Participants
34 Participants
n=7 Participants
24 Participants
n=5 Participants
10 Participants
n=4 Participants
45 Participants
n=21 Participants
13 Participants
n=10 Participants
4 Participants
n=115 Participants
55 Participants
n=6 Participants
236 Participants
n=6 Participants
Race/Ethnicity, Customized
More than one race
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
0 Participants
n=6 Participants
1 Participants
n=6 Participants
Race/Ethnicity, Customized
American Indian/Alaska native
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
1 Participants
n=6 Participants
1 Participants
n=6 Participants
Race/Ethnicity, Customized
Other: Brazilian
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=10 Participants
0 Participants
n=115 Participants
1 Participants
n=6 Participants
1 Participants
n=6 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
37 Units on a scale
n=5 Participants
22 Units on a scale
n=7 Participants
10 Units on a scale
n=5 Participants
9 Units on a scale
n=4 Participants
40 Units on a scale
n=21 Participants
12 Units on a scale
n=10 Participants
3 Units on a scale
n=115 Participants
29 Units on a scale
n=6 Participants
162 Units on a scale
n=6 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
16 Units on a scale
n=5 Participants
11 Units on a scale
n=7 Participants
13 Units on a scale
n=5 Participants
2 Units on a scale
n=4 Participants
5 Units on a scale
n=21 Participants
1 Units on a scale
n=10 Participants
1 Units on a scale
n=115 Participants
10 Units on a scale
n=6 Participants
59 Units on a scale
n=6 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status
2
0 Units on a scale
n=5 Participants
1 Units on a scale
n=7 Participants
1 Units on a scale
n=5 Participants
0 Units on a scale
n=4 Participants
0 Units on a scale
n=21 Participants
0 Units on a scale
n=10 Participants
0 Units on a scale
n=115 Participants
1 Units on a scale
n=6 Participants
3 Units on a scale
n=6 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status
3
0 Units on a scale
n=5 Participants
0 Units on a scale
n=7 Participants
0 Units on a scale
n=5 Participants
0 Units on a scale
n=4 Participants
0 Units on a scale
n=21 Participants
0 Units on a scale
n=10 Participants
0 Units on a scale
n=115 Participants
1 Units on a scale
n=6 Participants
1 Units on a scale
n=6 Participants
Eastern Cooperative Oncology Group (ECOG) Performance Status
Not reported
0 Units on a scale
n=5 Participants
0 Units on a scale
n=7 Participants
0 Units on a scale
n=5 Participants
0 Units on a scale
n=4 Participants
0 Units on a scale
n=21 Participants
0 Units on a scale
n=10 Participants
0 Units on a scale
n=115 Participants
17 Units on a scale
n=6 Participants
17 Units on a scale
n=6 Participants

PRIMARY outcome

Timeframe: Continuously from first dose to 70 days after last dose of study drug. For deaths, Day 1 of enrollment to 70 days after last dose of study drug.

Population: All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study

An AE is any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. An SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Drug-related is defined as having certain, probable, possible, or missing relationship to study drug. An IrAE is an AE characterized by a potential association with inflammation and considered by the investigator to be drug related. Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death.

Outcome measures

Outcome measures
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
n=53 Participants
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
n=34 Participants
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
n=24 Participants
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Extended Maintenance: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
AEs: Any Grade
51 Participants
33 Participants
24 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
AEs: Grade 3 or 4
18 Participants
10 Participants
10 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
AEs: Grade 5 (Fatal)
4 Participants
7 Participants
8 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
AEs leading to discontinuation: Any grade
13 Participants
6 Participants
8 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
AEs leading to discontinuation: Grade 3 or 4
9 Participants
3 Participants
6 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
AEs leading to discontinuation: Grade 5 (Fatal)
1 Participants
2 Participants
1 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
SAEs: Any grade
23 Participants
19 Participants
14 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
SAEs: Grade 3 or 4
13 Participants
8 Participants
5 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
SAEs: Grade 5 (Fatal)
4 Participants
7 Participants
8 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
Drug-related AEs: Any grade
42 Participants
28 Participants
21 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
Drug-related AEs: Grade 3 or 4
9 Participants
3 Participants
9 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
Drug-related AEs: Grade 5 (Fatal)
0 Participants
0 Participants
0 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
irAEs: Any grade
30 Participants
23 Participants
18 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
irAEs: Grade 3 or 4
7 Participants
2 Participants
6 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
irAEs: Grade 5 (Fatal)
0 Participants
0 Participants
0 Participants
Number of Participants With On-study Adverse Events (AEs), AEs Leading to Discontinuation, Serious Adverse Events (SAEs), Drug-related AEs, Immune-related AEs (irAEs), and Death as Outcome
Deaths
36 Participants
27 Participants
19 Participants

SECONDARY outcome

Timeframe: From first dose of study drug in parent study to death or date of last censoring.

Population: All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study

OS was computed for all patients who entered this study and is defined as the time between the first dose of study therapy and death. If a patient has not died, OS was censored at the time of last contact.

Outcome measures

Outcome measures
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
n=53 Participants
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
n=34 Participants
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
n=24 Participants
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Extended Maintenance: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Overall Survival (OS)
30.8 Months
Interval 24.2 to 41.1
18.7 Months
Interval 9.7 to 30.4
15.2 Months
Interval 10.7 to 21.4

SECONDARY outcome

Timeframe: From first dose of study drug in parent study to up to 2 years after reinduction

Population: All participants who received study drug as reinduction or extended maintenance from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study and those patients who were followed-up.

Survival rate was defined as the time from first dose of study drug to 1, 1.5, and 2 years.

Outcome measures

Outcome measures
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
n=53 Participants
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
n=34 Participants
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
n=24 Participants
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Extended Maintenance: Ipilimumab, 10 mg/kg
n=33 Participants
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 3 mg/kg
n=12 Participants
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 0.3 mg/kg
n=4 Participants
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
n=58 Participants
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Percentage of Participants Surviving at 1, 1.5, and 2 Years
1 year
80.9 Percentage of participants
55.9 Percentage of participants
65.6 Percentage of participants
100 Percentage of participants
100 Percentage of participants
75.0 Percentage of participants
87.8 Percentage of participants
Percentage of Participants Surviving at 1, 1.5, and 2 Years
1.5 years
71.3 Percentage of participants
50.0 Percentage of participants
35.0 Percentage of participants
100 Percentage of participants
84.6 Percentage of participants
75.0 Percentage of participants
79.0 Percentage of participants
Percentage of Participants Surviving at 1, 1.5, and 2 Years
2 years
63.6 Percentage of participants
38.2 Percentage of participants
30.6 Percentage of participants
91.0 Percentage of participants
84.6 Percentage of participants
75.0 Percentage of participants
64.9 Percentage of participants

SECONDARY outcome

Timeframe: From first dose of study drug during reinduction to the earliest of 70 days after last dose or day before second reinduction first dose date

Population: All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study 10 mg/kg current study

irAEs were defined as adverse events characterized by a potential association with inflammation and considered by the investigator as drug related. These prespecified terms were grouped into the following organ-specific subcategories: gastrointestinal, hepatic, skin, endocrine, neurologic, and other (includes blood, eye, immune system, investigations, infections, renal, and respiratory systems). Patients may have 1 or more events.

Outcome measures

Outcome measures
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
n=53 Participants
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
n=34 Participants
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
n=24 Participants
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Extended Maintenance: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Any irAE: Any grade
30 Participants
23 Participants
18 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Any irAE: Grade 3 or 4
7 Participants
2 Participants
6 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Any irAE: Grade 5 (Fatal)
0 Participants
0 Participants
0 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Gastrointestinal irAE: Any grade
11 Participants
7 Participants
14 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Gastrointestinal irAE: Grade 3 or 4
2 Participants
1 Participants
3 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Hepatic irAE: Any grade
3 Participants
0 Participants
1 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Hepatic irAE: Grade 3 or 4
2 Participants
0 Participants
1 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Endocrine irAE: Any grade
3 Participants
2 Participants
1 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Endocrine irAE: Grade 3 or 4
1 Participants
0 Participants
1 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Skin irAE: Any grade
18 Participants
18 Participants
10 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Skin irAE: Grade 3 or 4
2 Participants
1 Participants
1 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Neurologic irAE: Any grade
1 Participants
0 Participants
0 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Neurologic irAE: Grade 3 or 4
0 Participants
0 Participants
0 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Other irAE: Any grade
2 Participants
3 Participants
1 Participants
Number of Participants With On-study Immune-related Adverse Events (irAEs)
Other irAE: Grade 3 or 4
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From day of first reinduction in current study to date of progression or death, whichever occurred first.

Population: All participants who received study drug as reinduction from 0.3, 3, or 10 mg/kg doses in parent study and 10 mg/kg in current study

PFS was defined as the time between the date of the baseline tumor assessment in this study and the date of progression or death, whichever occurred first.

Outcome measures

Outcome measures
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
n=53 Participants
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
n=34 Participants
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
n=24 Participants
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
Extended Maintenance: Ipilimumab, 10 mg/kg
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 3 mg/kg
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance: Ipilimumab, 0.3 mg/kg
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Progression-free Survival (PFS)
3.4 Months
Interval 2.6 to 7.8
2.6 Months
Interval 2.6 to 2.8
2.6 Months
Interval 2.0 to 11.1

Adverse Events

First Reinduction: Ipilimumab, 10 to 10 mg/kg

Serious events: 23 serious events
Other events: 46 other events
Deaths: 0 deaths

First Reinduction: Ipilimumab, 3 to 10 mg/kg

Serious events: 19 serious events
Other events: 32 other events
Deaths: 0 deaths

First Reinduction: Ipilimumab, 0.3 to 10 mg/kg

Serious events: 14 serious events
Other events: 21 other events
Deaths: 0 deaths

First Reinduction: Ipilimumab, Other Dosage

Serious events: 7 serious events
Other events: 9 other events
Deaths: 0 deaths

Extended Maintenance Only: Ipilimumab, 10 mg/kg

Serious events: 12 serious events
Other events: 28 other events
Deaths: 0 deaths

Extended Maintenance Only: Ipilimumab, 3 mg/kg

Serious events: 3 serious events
Other events: 11 other events
Deaths: 0 deaths

Extended Maintenance Only: Ipilimumab, 0.3 mg/kg

Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths

Follow-up

Serious events: 20 serious events
Other events: 34 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
n=53 participants at risk
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
n=34 participants at risk
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
n=24 participants at risk
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, Other Dosage
n=11 participants at risk
Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
Extended Maintenance Only: Ipilimumab, 10 mg/kg
n=33 participants at risk
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance Only: Ipilimumab, 3 mg/kg
n=12 participants at risk
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance Only: Ipilimumab, 0.3 mg/kg
n=4 participants at risk
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
n=58 participants at risk
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Endocrine disorders
Hypothyroidism
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Ileus
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Abdominal pain
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Abdominal pain upper
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Endocrine disorders
Adrenal insufficiency
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Age-related macular degeneration
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Alanine aminotransferase increased
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Amylase increased
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Blood and lymphatic system disorders
Anaemia
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Anal fistula
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Arthralgia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Ascites
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Aspartate aminotransferase increased
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Asthenia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-cell lymphoma
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Bacteraemia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Hepatobiliary disorders
Bile duct stenosis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Blood creatine increased
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Blood creatinine increased
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Bone pain
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Cardiac disorders
Cardio-respiratory arrest
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Cellulitis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Central nervous system haemorrhage
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Cerebral ischaemia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Cerebrovascular accident
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Chills
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Hepatobiliary disorders
Cholecystitis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Hepatobiliary disorders
Cholecystitis chronic
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Blood and lymphatic system disorders
Coagulopathy
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Colitis
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
3/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Psychiatric disorders
Confusional state
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Constipation
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Cough
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Death
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Decreased appetite
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Dehydration
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Diabetes mellitus
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Diabetic ketoacidosis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Diabetic ketoacidotic hyperglycaemic coma
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Diarrhoea
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.8%
3/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
16.7%
4/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Diplegia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Disease progression
7.5%
4/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
14.7%
5/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
6/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
20.7%
12/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Dry eye
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Dysphagia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Dyspnoea
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Endocrine disorders
Endocrine disorder
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Eye pain
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Failure to thrive
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Fatigue
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Injury, poisoning and procedural complications
Femur fracture
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Gastrointestinal hypomotility
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
General physical health deterioration
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Glaucoma
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Haemoglobin decreased
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Headache
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Hyperglycaemia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Immune system disorders
Hypersensitivity
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Endocrine disorders
Hypophysitis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Endocrine disorders
Hypopituitarism
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Vascular disorders
Hypotension
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Influenza
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Injury, poisoning and procedural complications
Infusion related reaction
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Lactic acidosis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Cardiac disorders
Left ventricular dysfunction
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Endocrine disorders
Lymphocytic hypophysitis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Vascular disorders
Lymphoedema
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Toxic skin eruption
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Psychiatric disorders
Mental status changes
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Cardiac disorders
Myocardial infarction
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Nausea
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Obstruction gastric
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Ocular hyperaemia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Oral herpes
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Pancreatitis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Pathological fracture
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Periorbital oedema
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Vascular disorders
Phlebitis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Pneumonia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Pyrexia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Rash
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Rectal haemorrhage
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Renal and urinary disorders
Renal failure acute
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Retinal detachment
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Sepsis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Spinal cord compression
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Tracheal stenosis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Transient global amnesia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Renal and urinary disorders
Urinary bladder haemorrhage
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Urinary tract infection
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
VIIth nerve paralysis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Volvulus
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Vomiting
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014

Other adverse events

Other adverse events
Measure
First Reinduction: Ipilimumab, 10 to 10 mg/kg
n=53 participants at risk
Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 3 to 10 mg/kg
n=34 participants at risk
Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, 0.3 to 10 mg/kg
n=24 participants at risk
Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
First Reinduction: Ipilimumab, Other Dosage
n=11 participants at risk
Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
Extended Maintenance Only: Ipilimumab, 10 mg/kg
n=33 participants at risk
Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance Only: Ipilimumab, 3 mg/kg
n=12 participants at risk
Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Extended Maintenance Only: Ipilimumab, 0.3 mg/kg
n=4 participants at risk
Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
Follow-up
n=58 participants at risk
Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
Infections and infestations
Cystitis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Abdominal pain
13.2%
7/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
11.8%
4/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.1%
4/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Abdominal pain lower
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Abdominal pain upper
11.3%
6/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Acne
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Alanine aminotransferase increased
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.1%
4/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Alopecia
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Amylase increased
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Blood and lymphatic system disorders
Anaemia
9.4%
5/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.1%
4/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Psychiatric disorders
Anxiety
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Psychiatric disorders
Apathy
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Arthralgia
9.4%
5/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
14.7%
5/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.5%
3/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Arthritis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Aspartate aminotransferase increased
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
15.2%
5/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Asthenia
13.2%
7/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
11.8%
4/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
18.2%
2/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Hepatobiliary disorders
Autoimmune hepatitis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Axillary pain
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Back pain
11.3%
6/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
17.6%
6/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
18.2%
2/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.1%
4/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Blister
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Blood alkaline phosphatase increased
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Blood creatinine increased
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Blood thyroid stimulating hormone increased
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Blood uric acid increased
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Blood urine present
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Bronchitis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Burning sensation
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Cataract
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Chills
11.3%
6/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.1%
4/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Hepatobiliary disorders
Cholecystitis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Colitis
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.5%
3/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.1%
4/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Constipation
11.3%
6/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
14.7%
5/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
16.7%
4/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
18.2%
2/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Injury, poisoning and procedural complications
Contusion
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Cough
15.1%
8/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
14.7%
5/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.5%
3/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
27.3%
3/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
21.2%
7/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Decreased appetite
17.0%
9/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
14.7%
5/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
20.8%
5/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
45.5%
5/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
16.7%
2/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Dehydration
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.5%
3/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Diarrhoea
32.1%
17/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
23.5%
8/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
37.5%
9/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
36.4%
4/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
48.5%
16/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
33.3%
4/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.2%
3/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Dizziness
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
18.2%
2/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Dry mouth
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Dry skin
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Dysgeusia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Dyspepsia
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.5%
3/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
18.2%
2/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Dyspnoea
7.5%
4/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
20.6%
7/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.5%
3/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Erysipelas
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Erythema
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Erythema of eyelid
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Exfoliative rash
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Eyelid oedema
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Fatigue
37.7%
20/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
32.4%
11/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
41.7%
10/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
54.5%
6/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
24.2%
8/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
33.3%
4/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
20.7%
12/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Flatulence
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Vascular disorders
Flushing
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Folliculitis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Gamma-glutamyltransferase increased
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Haemoglobin decreased
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.8%
3/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Headache
11.3%
6/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
20.6%
7/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
27.3%
3/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
15.2%
5/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Urinary tract infection
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Herpes zoster
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Hiatus hernia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Urticaria
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Hyperglycaemia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Hyperhidrosis
7.5%
4/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Immune system disorders
Hypersensitivity
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Vascular disorders
Hypertension
7.5%
4/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
3/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Hypokalaemia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Metabolism and nutrition disorders
Hyponatraemia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Vascular disorders
Hypotension
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Endocrine disorders
Hypothyroidism
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Influenza like illness
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Infusion site extravasation
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Inguinal hernia
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Psychiatric disorders
Insomnia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.8%
3/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.5%
3/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
15.2%
5/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Iritis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Psychiatric disorders
Libido decreased
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Local swelling
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Endocrine disorders
Lymphocytic hypophysitis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic pain
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Migraine
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/1 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Muscle spasms
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Muscle tightness
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.8%
3/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
3/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.2%
3/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Myalgia
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Nasopharyngitis
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.1%
4/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.2%
3/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Nausea
28.3%
15/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
11.8%
4/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
29.2%
7/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
36.4%
4/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
15.2%
5/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
16.7%
2/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.6%
5/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Nervous system disorders
Neuropathy peripheral
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Oedema peripheral
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Pain
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
12.5%
3/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.2%
3/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Musculoskeletal and connective tissue disorders
Pain in extremity
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.8%
3/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
16.7%
2/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
10.3%
6/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Photophobia
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Productive cough
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Pruritus
24.5%
13/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
35.3%
12/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
6/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
27.3%
3/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
30.3%
10/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
3/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
13.8%
8/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Pyrexia
9.4%
5/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
20.6%
7/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
16.7%
4/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Injury, poisoning and procedural complications
Radiation skin injury
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Rash
18.9%
10/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
29.4%
10/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
16.7%
4/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
36.4%
4/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
18.2%
6/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
33.3%
4/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
10.3%
6/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Retinopathy
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Sinusitis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Skin hypopigmentation
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
2.9%
1/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.0%
1/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
25.0%
1/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Skin mass
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Stomatitis
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Tinea cruris
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Infections and infestations
Upper respiratory tract infection
5.7%
3/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.8%
3/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
15.2%
5/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Vision blurred
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Eye disorders
Visual acuity reduced
3.8%
2/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
1/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Skin and subcutaneous tissue disorders
Vitiligo
1.9%
1/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
4.2%
1/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
3/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Gastrointestinal disorders
Vomiting
17.0%
9/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
5.9%
2/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.3%
2/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
18.2%
2/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
1.7%
1/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
Investigations
Weight decreased
9.4%
5/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
8.8%
3/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
16.7%
4/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
9.1%
1/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
3.4%
2/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
General disorders
Xerosis
0.00%
0/53 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/34 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/24 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/11 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
6.1%
2/33 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/12 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/4 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014
0.00%
0/58 • From date of first re-induction first dose to the earliest of 70 days after first re-induction/maintenance last dose date or day before second re-induction first dose date, up to April 2014 (approximately 7 years)
Study initiated: May 2006; Study Completion: April 2014

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Results disclosure agreements

  • Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
  • Publication restrictions are in place

Restriction type: OTHER