Trial Outcomes & Findings for Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies (NCT NCT00142298)
NCT ID: NCT00142298
Last Updated: 2020-08-21
Results Overview
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1869 participants
Primary outcome timeframe
156 weeks, 208 weeks (from feeder study baseline)
Results posted on
2020-08-21
Participant Flow
An open-label trial of telbivudine in adults with chronic hepatitis B previously treated in Idenix-sponsored telbivudine studies. Study start March 2005 and completed November 2009.
Participant milestones
| Measure |
Group A : LdT Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A : LAM Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 2401
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group B: LdT 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group B: LAM 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group C: LdT Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C: LAM Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C: Other Feeder Studies
Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Safety Population
|
655
|
626
|
122
|
206
|
50
|
26
|
23
|
66
|
57
|
13
|
|
Overall Study
STARTED
|
667
|
632
|
123
|
206
|
56
|
26
|
23
|
66
|
57
|
13
|
|
Overall Study
Per Protocol Population
|
635
|
606
|
120
|
202
|
50
|
25
|
19
|
64
|
56
|
13
|
|
Overall Study
COMPLETED
|
507
|
456
|
90
|
121
|
46
|
10
|
15
|
58
|
52
|
13
|
|
Overall Study
NOT COMPLETED
|
160
|
176
|
33
|
85
|
10
|
16
|
8
|
8
|
5
|
0
|
Reasons for withdrawal
| Measure |
Group A : LdT Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A : LAM Pool 2302/015
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 2401
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group B: LdT 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group B: LAM 2301
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group C: LdT Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C: LAM Pool 2302/015
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C: Other Feeder Studies
Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
10
|
10
|
1
|
5
|
2
|
2
|
0
|
0
|
0
|
0
|
|
Overall Study
Clinical disease progression
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
1
|
1
|
1
|
0
|
0
|
6
|
0
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
44
|
62
|
9
|
12
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Non-compliance
|
15
|
13
|
0
|
6
|
1
|
0
|
0
|
3
|
3
|
0
|
|
Overall Study
Patient, Investigator,or Sponsor request
|
66
|
60
|
11
|
51
|
4
|
3
|
1
|
4
|
1
|
0
|
|
Overall Study
Pregnancy
|
4
|
4
|
2
|
3
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Virologic breakthrough
|
19
|
23
|
9
|
7
|
2
|
3
|
3
|
0
|
0
|
0
|
|
Overall Study
Other- not specified
|
0
|
3
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Treatment Failure
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
0
|
0
|
Baseline Characteristics
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
Baseline characteristics by cohort
| Measure |
Group A : LdT Pool 2302/015
n=667 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A : LAM Pool 2302/015
n=632 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 2401
n=123 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 2402
n=206 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
n=56 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group B: LdT 2301
n=26 Participants
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group B: LAM 2301
n=23 Participants
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group C: LdT Pool 2302/015
n=66 Participants
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C: LAM Pool 2302/015
n=57 Participants
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C: Other Feeder Studies
n=13 Participants
Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Total
n=1869 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
< 30 years
|
276 Participants
n=99 Participants
|
207 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
54 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
30 Participants
n=6 Participants
|
27 Participants
n=114 Participants
|
8 Participants
|
663 Participants
n=19 Participants
|
|
Age, Customized
30-50 years
|
320 Participants
n=99 Participants
|
325 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
122 Participants
n=7 Participants
|
40 Participants
n=31 Participants
|
10 Participants
n=30 Participants
|
5 Participants
n=3 Participants
|
31 Participants
n=6 Participants
|
24 Participants
n=114 Participants
|
5 Participants
|
948 Participants
n=19 Participants
|
|
Age, Customized
> 50 years
|
71 Participants
n=99 Participants
|
100 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
30 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
5 Participants
n=6 Participants
|
6 Participants
n=114 Participants
|
0 Participants
|
258 Participants
n=19 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=99 Participants
|
142 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
53 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
9 Participants
n=30 Participants
|
6 Participants
n=3 Participants
|
20 Participants
n=6 Participants
|
14 Participants
n=114 Participants
|
3 Participants
|
433 Participants
n=19 Participants
|
|
Sex: Female, Male
Male
|
520 Participants
n=99 Participants
|
490 Participants
n=107 Participants
|
93 Participants
n=206 Participants
|
153 Participants
n=7 Participants
|
47 Participants
n=31 Participants
|
17 Participants
n=30 Participants
|
17 Participants
n=3 Participants
|
46 Participants
n=6 Participants
|
43 Participants
n=114 Participants
|
10 Participants
|
1436 Participants
n=19 Participants
|
PRIMARY outcome
Timeframe: 156 weeks, 208 weeks (from feeder study baseline)Population: Per protocol (PP) population. The PP analysis was done on separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Outcome measures
| Measure |
Group A : LdT Pool 2302/015
n=635 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A: Feeder Study 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]
HBeAg Positive: week 156 (n=338)
|
67.2 Percentage of participants
Interval 61.9 to 72.1
|
—
|
—
|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]
HBeAg Positive: week 208 (n=252)
|
73.8 Percentage of participants
Interval 67.9 to 79.1
|
—
|
—
|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]
HBeAg Negative: week 156 (n=197)
|
81.7 Percentage of participants
Interval 75.6 to 86.9
|
—
|
—
|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]
HBeAg Negative: week 208 (n=168)
|
86.3 Percentage of participants
Interval 80.2 to 91.1
|
—
|
—
|
PRIMARY outcome
Timeframe: 52 weeks, 104 weeksPopulation: Per protocol (PP) population. The PP analysis was done separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Outcome measures
| Measure |
Group A : LdT Pool 2302/015
n=606 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A: Feeder Study 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]
HBeAg Positive: week 52 (n=338)
|
60.1 Percentage of Participants
Interval 54.6 to 65.3
|
—
|
—
|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]
HBeAg Positive: week 104 (n=101)
|
65.3 Percentage of Participants
Interval 55.2 to 74.5
|
—
|
—
|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]
HBeAg Negative: week 52 (n=182)
|
80.8 Percentage of Participants
Interval 74.3 to 86.2
|
—
|
—
|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]
HBeAg Negative: week 104 (n=79)
|
81.0 Percentage of Participants
Interval 70.6 to 89.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 52 weeks, 104 weeksPopulation: Per protocol (PP) population. The PP analysis was done on the PP population, separately for the HBeAg-positive and HBeAg-negative subpopulation (status as feeder baseline). n = the number of HBeAg-positive/HBeAg-negative patients who were eligible for maintained therapeutic response.
The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Outcome measures
| Measure |
Group A : LdT Pool 2302/015
n=120 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A: Feeder Study 2402
n=131 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
n=50 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]
HBeAg Positive: 52 week (n = 103, 79, 43)
|
77.7 Percentage of Participants
Interval 68.4 to 85.3
|
35.4 Percentage of Participants
Interval 25.0 to 47.0
|
69.8 Percentage of Participants
Interval 53.9 to 82.8
|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]
HBeAg Positive: 104 week (n = 66, 15, 30)
|
81.8 Percentage of Participants
Interval 70.4 to 90.2
|
46.7 Percentage of Participants
Interval 21.3 to 73.4
|
76.7 Percentage of Participants
Interval 57.7 to 90.1
|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]
HBeAg Negative: 52 week (n = 0, 37, 0)
|
NA Percentage of Participants
In per protocol population, all participants from feeder study 2401 are HBeAg-positive. So, no analysis was done at week 52.
|
54.1 Percentage of Participants
Interval 36.9 to 70.5
|
NA Percentage of Participants
In per protocol population, all participants from feeder study 010 are HBeAg-positive. So, no analysis was done at week 52.
|
|
Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]
HBeAg Negative: 104 week (n = 0, 10, 0)
|
NA Percentage of Participants
In per protocol population, all participants from feeder study 2401 are HBeAg-positive. So, no analysis was done at week 104.
|
60.0 Percentage of Participants
Interval 26.2 to 87.8
|
NA Percentage of Participants
In per protocol population, all participants from feeder study 010 are HBeAg-positive. So, no analysis was done at week 104.
|
PRIMARY outcome
Timeframe: 156 weeks, 208 weeks (from feeder study baseline)Population: Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.
Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
Outcome measures
| Measure |
Group A : LdT Pool 2302/015
n=25 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A: Feeder Study 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
HBeAg Positive: week 156 (n= 4)
|
100 Percentage of Participants
Interval 39.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
HBeAg Positive: week 208 (n= 1)
|
100 Percentage of Participants
Interval 2.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
HBeAg Negative: week 156 (n= 11)
|
72.7 Percentage of Participants
Interval 39.0 to 94.0
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
HBeAg Negative: week 208 (n= 7)
|
71.4 Percentage of Participants
Interval 29.0 to 96.3
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
Overall: Week 156 (n= 15)
|
80.0 Percentage of Participants
Interval 51.9 to 95.7
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]
Overall: Week 208 (n= 8)
|
75.0 Percentage of Participants
Interval 34.9 to 96.8
|
—
|
—
|
PRIMARY outcome
Timeframe: 52 weeks,104 weeksPopulation: Per protocol (PP) population. The PP analysis was done on the overall PP population and separately for the HBeAg-positive and HBeAg-negative subpopulation (status at feeder baseline). n = the number of patients who were eligible for maintained clinical response.
Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.
Outcome measures
| Measure |
Group A : LdT Pool 2302/015
n=19 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A: Feeder Study 2402
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
HBeAg Positive: week 52 (n=4)
|
100 Percentage of Participants
Interval 39.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
HBeAg Positive: week 104 (n=1)
|
100 Percentage of Participants
Interval 2.5 to 100.0
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
HBeAg Negative: week 52 (n=11)
|
72.7 Percentage of Participants
Interval 39.9 to 94.0
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
HBeAg Negative: week 104 (n=5)
|
100 Percentage of Participants
Interval 47.8 to 100.0
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
Overall: week 52 (n= 15)
|
80.0 Percentage of Participants
Interval 51.9 to 95.7
|
—
|
—
|
|
Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]
Overall: week 104 (n= 6)
|
100 Percentage of Participants
Interval 54.1 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 52 weeks,104 weeksPopulation: The per protocol population. n= is the number of HBeAg-positive/HBeAg-negative patients from per protocol population who achieved maintained response at the end of treatment and had off-treatment assessment to determine the sustained response at that time point or lost sustained response before the off-treatment timepoint.
The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.
Outcome measures
| Measure |
Group A : LdT Pool 2302/015
n=64 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A: Feeder Study 2402
n=56 Participants
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
|---|---|---|---|
|
Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]
HBeAg Positive: week 52 (n= 53, 42)
|
69.8 Percentage of Participants
Interval 55.7 to 81.7
|
73.8 Percentage of Participants
Interval 58.0 to 86.1
|
—
|
|
Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]
HBeAg Positive: week 104 (n= 42, 32)
|
57.1 Percentage of Participants
Interval 41.0 to 72.3
|
62.5 Percentage of Participants
Interval 43.7 to 78.9
|
—
|
|
Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]
HBeAg Negative: week 52 (n= 3, 5)
|
0.0 Percentage of Participants
Interval 0.0 to 70.8
|
80.0 Percentage of Participants
Interval 28.4 to 99.5
|
—
|
|
Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]
HBeAg Negative: week 104 (n= 3, 6)
|
0.0 Percentage of Participants
Interval 0.0 to 70.8
|
83.3 Percentage of Participants
Interval 35.9 to 99.6
|
—
|
PRIMARY outcome
Timeframe: 52 weeks,104 weeksPopulation: In "Group C: other feeder study" reporting group, there were only 13 patients; hence, no summary statistics were performed. Only listings were generated.
The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeks, 104 weeks, 156 weeks, 208 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeks, 104 weeks, 156 weeks, 208 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeks, 104 weeks, 156 weeks, 208 weeksOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 52 weeks, 104 weeks, 156 weeks, 208 weeksOutcome measures
Outcome data not reported
Adverse Events
Group A : LdT Pool 2302/015
Serious events: 45 serious events
Other events: 318 other events
Deaths: 0 deaths
Group A : LAM Pool 2302/015
Serious events: 21 serious events
Other events: 309 other events
Deaths: 0 deaths
Group A: Feeder Study 010
Serious events: 3 serious events
Other events: 24 other events
Deaths: 0 deaths
Group A: Feeder 2401
Serious events: 10 serious events
Other events: 74 other events
Deaths: 0 deaths
Group A: Feeder 2402
Serious events: 14 serious events
Other events: 88 other events
Deaths: 0 deaths
Group B: LdT 2301
Serious events: 16 serious events
Other events: 21 other events
Deaths: 0 deaths
Group B: Lam 2301
Serious events: 10 serious events
Other events: 19 other events
Deaths: 0 deaths
Group C : LdT Pool 2302/015
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
Group C: Lam Pool 2302/015
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Group C : Other Feeder Studies
Serious events: 2 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A : LdT Pool 2302/015
n=655 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A : LAM Pool 2302/015
n=626 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
n=50 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder 2401
n=122 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder 2402
n=206 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group B: LdT 2301
n=26 participants at risk
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group B: Lam 2301
n=23 participants at risk
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group C : LdT Pool 2302/015
n=66 participants at risk
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C: Lam Pool 2302/015
n=57 participants at risk
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C : Other Feeder Studies
n=13 participants at risk
Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
DENGUE FEVER
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
DENTAL CARIES
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
EPIGLOTTITIS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
HEPATITIS B
|
0.46%
3/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.80%
5/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Blood and lymphatic system disorders
APLASIA PURE RED CELL
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Ear and labyrinth disorders
VESTIBULAR NEURONITIS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
ENTERITIS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
INGUINAL HERNIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
LARGE INTESTINE PERFORATION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
MELAENA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
NAUSEA
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
OESOPHAGEAL HAEMORRHAGE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
PANCREATITIS ACUTE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
PERITONEAL ADHESIONS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
VOMITING
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
APLASIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
CONCOMITANT DISEASE PROGRESSION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
DEATH
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Hepatobiliary disorders
CHOLANGITIS ACUTE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Hepatobiliary disorders
CHRONIC HEPATITIS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Hepatobiliary disorders
HEPATITIS
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Hepatobiliary disorders
HEPATOMEGALY
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
APPENDICITIS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
BRONCHITIS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
CELLULITIS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
LEPTOSPIROSIS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
PHARYNGITIS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
PNEUMONIA
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
POSTOPERATIVE INFECTION
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
SINUSITIS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
UROSEPSIS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
EXCORIATION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
FALL
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
FIBULA FRACTURE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
JOINT DISLOCATION
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
JOINT LIGAMENT RUPTURE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
JOINT SPRAIN
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
LIMB INJURY
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
LOWER LIMB FRACTURE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
ROAD TRAFFIC ACCIDENT
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
SKIN LACERATION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
TOOTH INJURY
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
WRIST FRACTURE
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.61%
4/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.32%
2/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Investigations
WEIGHT DECREASED
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS INADEQUATE CONTROL
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Metabolism and nutrition disorders
DIABETIC HYPEROSMOLAR NON-KETOACIDOSIS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Metabolism and nutrition disorders
FLUID OVERLOAD
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE ATROPHY
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
MYOPATHY
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
POLYMYOSITIS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
ROTATOR CUFF SYNDROME
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
ACOUSTIC NEUROMA
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BILE DUCT CANCER
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
COLON CANCER
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
DIFFUSE LARGE B-CELL LYMPHOMA
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTRIC CANCER
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM MALIGNANT
|
0.76%
5/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
30.8%
8/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
13.0%
3/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LYMPHOMA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NASAL NEOPLASM BENIGN
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
POLYP
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PROLACTINOMA
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
RENAL CELL CARCINOMA STAGE UNSPECIFIED
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
THYROID GLAND CANCER
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
DIABETIC HYPEROSMOLAR COMA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
DIZZINESS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
HEADACHE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION MISSED
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Pregnancy, puerperium and perinatal conditions
ABORTION SPONTANEOUS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Psychiatric disorders
ADJUSTMENT DISORDER
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Psychiatric disorders
DEPRESSION
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Psychiatric disorders
HYPOMANIA
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
CALCULUS URETERIC
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
CALCULUS URINARY
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS PROLIFERATIVE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
OBSTRUCTIVE UROPATHY
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
PROTEINURIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Reproductive system and breast disorders
METRORRHAGIA
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Reproductive system and breast disorders
PROSTATIC HYPERTROPHY
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Reproductive system and breast disorders
VULVAL ANGIOKERATOMA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Respiratory, thoracic and mediastinal disorders
CATARRH
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL MUCOSAL DISORDER
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL SEPTUM DEVIATION
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL TURBINATE ABNORMALITY
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Surgical and medical procedures
ABORTION INDUCED
|
0.61%
4/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.32%
2/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Surgical and medical procedures
FRACTURE TREATMENT
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Vascular disorders
BLEEDING VARICOSE VEIN
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
Other adverse events
| Measure |
Group A : LdT Pool 2302/015
n=655 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group A : LAM Pool 2302/015
n=626 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder Study 010
n=50 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder 2401
n=122 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group A: Feeder 2402
n=206 participants at risk
Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group B: LdT 2301
n=26 participants at risk
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
|
Group B: Lam 2301
n=23 participants at risk
Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
|
Group C : LdT Pool 2302/015
n=66 participants at risk
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C: Lam Pool 2302/015
n=57 participants at risk
Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
Group C : Other Feeder Studies
n=13 participants at risk
Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
THROMBOCYTHAEMIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
1.5%
10/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.1%
13/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.2%
8/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
10/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.9%
8/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
13.0%
3/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
4.0%
26/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.4%
15/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
6.0%
3/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.1%
5/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.4%
5/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
11.5%
3/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
13.0%
3/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.5%
3/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.5%
2/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
ABDOMINAL SYMPTOM
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.7%
11/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.3%
8/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
6.0%
3/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
DIARRHOEA
|
3.2%
21/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.4%
21/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.0%
2/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
17.4%
4/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.5%
3/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.5%
2/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
1.8%
12/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.9%
12/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.3%
4/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.0%
2/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.5%
2/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
HAEMORRHOIDAL HAEMORRHAGE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
NAUSEA
|
1.5%
10/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.9%
18/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.0%
2/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.5%
3/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
11.5%
3/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Gastrointestinal disorders
VOMITING
|
0.92%
6/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.4%
9/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.0%
2/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
ASTHENIA
|
1.4%
9/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.96%
6/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.9%
6/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.9%
4/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
FATIGUE
|
4.4%
29/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
5.3%
33/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.0%
2/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
5.7%
7/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.4%
5/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
21.7%
5/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
18.2%
12/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
5.3%
3/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
23.1%
3/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
MALAISE
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.32%
2/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.61%
4/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.64%
4/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
15.4%
4/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
17.4%
4/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
PITTING OEDEMA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
General disorders
PYREXIA
|
1.7%
11/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
11/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.9%
4/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
15.4%
4/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.0%
2/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Hepatobiliary disorders
HEPATIC LESION
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Hepatobiliary disorders
HEPATIC STEATOSIS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.1%
7/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.5%
3/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
BODY TINEA
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
GASTROENTERITIS
|
0.76%
5/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.80%
5/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
HEPATITIS B
|
2.4%
16/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.1%
7/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
6.0%
3/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.4%
9/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.0%
2/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
INFLUENZA
|
3.8%
25/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.5%
22/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
22.0%
11/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.9%
6/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
6.1%
4/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
5.3%
3/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
NASOPHARYNGITIS
|
10.5%
69/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
11.7%
73/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
14.8%
18/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.9%
6/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
13.0%
3/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.0%
2/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
TINEA VERSICOLOUR
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
TONSILLITIS
|
0.61%
4/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.32%
2/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
7.6%
50/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
9.6%
60/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.0%
2/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
19.7%
24/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.4%
9/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
15.4%
4/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
17.4%
4/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
22.7%
15/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
24.6%
14/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.48%
3/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
11.5%
3/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
JOINT SPRAIN
|
0.61%
4/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.64%
4/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL PAIN
|
0.61%
4/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
2.7%
18/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.9%
12/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.4%
9/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
15.4%
2/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Investigations
BLOOD CREATINE PHOSPHOKINASE INCREASED
|
8.5%
56/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.5%
47/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.0%
2/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.1%
5/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
11.7%
24/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
11.5%
3/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
17.4%
4/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.0%
2/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
15.4%
2/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Investigations
HBV DNA INCREASED
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
5.8%
12/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Investigations
WEIGHT DECREASED
|
0.46%
3/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.64%
4/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
3/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Investigations
WEIGHT INCREASED
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS NON-INSULIN-DEPENDENT
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Metabolism and nutrition disorders
HYPERCHOLESTEROLAEMIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.5%
2/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
2.7%
18/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.4%
15/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.3%
4/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.9%
6/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
13.0%
3/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
2.4%
16/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.6%
16/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.9%
8/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.5%
3/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.5%
2/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
15.4%
2/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CRAMP
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
0.46%
3/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
6.0%
3/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.76%
5/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
1.2%
8/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
10/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.6%
2/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
5.3%
3/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATIC NEOPLASM
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
DIZZINESS
|
1.1%
7/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.1%
7/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.3%
4/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.9%
4/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.3%
1/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.0%
2/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Nervous system disorders
HEADACHE
|
4.3%
28/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.5%
28/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.0%
2/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.1%
5/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.4%
9/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.0%
2/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
15.4%
2/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Psychiatric disorders
DEPRESSION
|
0.76%
5/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.64%
4/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.5%
1/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
GLOMERULONEPHRITIS PROLIFERATIVE
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.5%
2/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
4.1%
27/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.5%
22/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.3%
4/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
5.8%
12/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
11.5%
3/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.5%
3/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.0%
4/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
0.46%
3/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.32%
2/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGOLARYNGEAL PAIN
|
2.6%
17/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
11/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
5.7%
7/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.4%
5/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.5%
3/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Respiratory, thoracic and mediastinal disorders
RHINITIS ALLERGIC
|
0.76%
5/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.5%
3/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Skin and subcutaneous tissue disorders
ACNE
|
0.15%
1/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.48%
3/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Skin and subcutaneous tissue disorders
ECZEMA
|
0.46%
3/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.48%
3/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.0%
1/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Skin and subcutaneous tissue disorders
PALMAR ERYTHEMA
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.16%
1/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.82%
1/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
1.8%
1/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Skin and subcutaneous tissue disorders
PSORIASIS
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
6.0%
3/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Skin and subcutaneous tissue disorders
RASH
|
1.8%
12/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.96%
6/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
5.7%
7/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.97%
2/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.0%
2/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
15.4%
2/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Skin and subcutaneous tissue disorders
SPIDER NAEVUS
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Surgical and medical procedures
EYE OPERATION
|
0.00%
0/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Vascular disorders
HYPERTENSION
|
1.7%
11/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
2.4%
15/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
4.1%
5/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.49%
1/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
3.8%
1/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
8.7%
2/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
1/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
|
Vascular disorders
VARICOSE VEIN
|
0.31%
2/655
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/626
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/50
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/122
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/206
All safety analyses were performed on the safety populations defined for each reporting group.
|
7.7%
2/26
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/23
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/66
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/57
All safety analyses were performed on the safety populations defined for each reporting group.
|
0.00%
0/13
All safety analyses were performed on the safety populations defined for each reporting group.
|
Additional Information
Study Director
Novartis Pharmaceuticals
Phone: 862-778-8300
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial; or the publication of the trial results in their entirety.
- Publication restrictions are in place
Restriction type: OTHER