Trial Outcomes & Findings for An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis (NCT NCT00488631)
NCT ID: NCT00488631
Last Updated: 2016-04-26
Results Overview
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1228 participants
Primary outcome timeframe
Induction Baseline, Week 0 through Week 54
Results posted on
2016-04-26
Participant Flow
Efficacy results are based on participants who were Golimumab induction responders (GLM-I-Rsp) and were randomly assigned to GLM-I-Rsp-Placebo Maintenance, GLM-I-Rsp-Golimumab 50 mg and GLM-I-Rsp-Golimumab 100 mg as per planned analysis.
Participant milestones
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance
Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
PBO-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
|
GLM-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
|
Placebo Extension
Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
|
Golimumab 50 mg - Extension
Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
|
Golimumab 100 mg Extension
Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
|
Golimumab 200 mg Extension
Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double Blind Period (Week 0-54)
STARTED
|
156
|
154
|
154
|
129
|
230
|
405
|
0
|
0
|
0
|
0
|
|
Double Blind Period (Week 0-54)
COMPLETED
|
113
|
111
|
109
|
88
|
127
|
189
|
0
|
0
|
0
|
0
|
|
Double Blind Period (Week 0-54)
NOT COMPLETED
|
43
|
43
|
45
|
41
|
103
|
216
|
0
|
0
|
0
|
0
|
|
Open Label Study Extension (Week 54-228)
STARTED
|
0
|
0
|
0
|
0
|
0
|
0
|
96
|
93
|
470
|
7
|
|
Open Label Study Extension (Week 54-228)
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
16
|
66
|
288
|
4
|
|
Open Label Study Extension (Week 54-228)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
80
|
27
|
182
|
3
|
Reasons for withdrawal
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance
Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
PBO-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
|
GLM-I-nonRsp-Golimumab 100 mg Maintenance
Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
|
Placebo Extension
Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
|
Golimumab 50 mg - Extension
Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
|
Golimumab 100 mg Extension
Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
|
Golimumab 200 mg Extension
Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Double Blind Period (Week 0-54)
Adverse Event
|
17
|
12
|
12
|
12
|
30
|
50
|
0
|
0
|
0
|
0
|
|
Double Blind Period (Week 0-54)
Death
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Double Blind Period (Week 0-54)
Unsatisfactory therapeutic effect
|
19
|
17
|
22
|
18
|
56
|
124
|
0
|
0
|
0
|
0
|
|
Double Blind Period (Week 0-54)
Lost to Follow-up
|
1
|
2
|
1
|
0
|
3
|
7
|
0
|
0
|
0
|
0
|
|
Double Blind Period (Week 0-54)
Other
|
6
|
12
|
10
|
11
|
14
|
34
|
0
|
0
|
0
|
0
|
|
Open Label Study Extension (Week 54-228)
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
10
|
8
|
54
|
0
|
|
Open Label Study Extension (Week 54-228)
Death
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Open Label Study Extension (Week 54-228)
Unsatisfactory therapeutic effect
|
0
|
0
|
0
|
0
|
0
|
0
|
5
|
5
|
34
|
3
|
|
Open Label Study Extension (Week 54-228)
Lost to Follow-up
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
0
|
6
|
0
|
|
Open Label Study Extension (Week 54-228)
Unspecified reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
63
|
14
|
87
|
0
|
Baseline Characteristics
An Efficacy and Safety Study of Golimumab (CNTO 148) in Participants With Moderately to Severely Active Ulcerative Colitis
Baseline characteristics by cohort
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
n=156 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
n=154 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
n=154 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance
n=129 Participants
Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
PBO-I-nonRsp-Golimumab 100 mg Maintenance
n=230 Participants
Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
|
GLM-I-nonRsp-Golimumab 100 mg Maintenance
n=405 Participants
Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
|
Total
n=1228 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 14.05 • n=93 Participants
|
41.4 years
STANDARD_DEVIATION 13.84 • n=4 Participants
|
39.1 years
STANDARD_DEVIATION 13.11 • n=27 Participants
|
38 years
STANDARD_DEVIATION 13.27 • n=483 Participants
|
40.3 years
STANDARD_DEVIATION 12.67 • n=36 Participants
|
41.2 years
STANDARD_DEVIATION 13.6 • n=10 Participants
|
40.3 years
STANDARD_DEVIATION 13.44 • n=115 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
99 Participants
n=36 Participants
|
138 Participants
n=10 Participants
|
528 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=93 Participants
|
77 Participants
n=4 Participants
|
89 Participants
n=27 Participants
|
61 Participants
n=483 Participants
|
131 Participants
n=36 Participants
|
267 Participants
n=10 Participants
|
700 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Induction Baseline, Week 0 through Week 54Population: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Clinical response is defined as decrease from induction baseline in Mayo score by greater than or equal to (\>=) 30 percent and \>= 3, with either decrease from induction baseline in rectal bleeding subscore of \>= 1 or rectal bleeding subscore of 0 or 1. Participants who lost clinical response prior to Week 54 were considered not to meet endpoint. Mayo score is sum of 4 subscores (ie, stool frequency, rectal bleeding, endoscopic findings, physician's global assessment); each rated on scale from 0 to 3, with higher scores indicating more severe disease. Total Mayo score value ranges from 0 to 12.
Outcome measures
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
n=154 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
n=151 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
n=151 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
|---|---|---|---|
|
Number of Participants in Clinical Response Through Week 54
|
48 Participants
|
71 Participants
|
75 Participants
|
SECONDARY outcome
Timeframe: Week 30 and Week 54Population: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
Outcome measures
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
n=154 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
n=151 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
n=151 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
|---|---|---|---|
|
Number of Participants With Clinical Remission at Both Week 30 and Week 54
|
24 Participants
|
35 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: Week 30 and Week 54Population: Primary analysis population included randomly assigned participants in clinical response to golimumab induction at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Mucosal healing is determined from the endoscopy sub-score of the Mayo score. Mucosal healing is defined as an endoscopy sub-score of 0 or 1. Higher score indicates higher severity of disease. Endoscopy sub-score ranges from 0 (normal or inactive disease) to 3 (severe disease; spontaneous bleeding and ulceration). The number of participants with mucosal healing at both the weeks that is Week 30 as well as Week 54 will be reported.
Outcome measures
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
n=154 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
n=151 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
n=151 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
|---|---|---|---|
|
Number of Participants With Mucosal Healing at Both Week 30 and Week 54
|
41 Participants
|
63 Participants
|
64 Participants
|
SECONDARY outcome
Timeframe: Week 30 and Week 54Population: Analysis population included randomly assigned participants who were in clinical remission to golimumab induction at Week 0 of the maintenance study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12. The number of participants in clinical remission at both the weeks that is Week 30 as well as Week 54 will be reported.
Outcome measures
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
n=54 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
n=52 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
n=54 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
|---|---|---|---|
|
Number of Participants With Clinical Remission at Both Week 30 and 54 Among Participants With Clinical Remission at Week 0 of Maintenance Study
|
13 Participants
|
19 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Week 54Population: Analysis population included randomly assigned participants in clinical response to golimumab induction who were receiving concomitant corticosteroids at Week 0 of the study. 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure.
Clinical remission is defined as a Mayo score of less than or equal to 2, with no individual sub-score greater than 1. The Mayo score is sum of 4 sub-scores (i.e., stool frequency, rectal bleeding, endoscopic findings, and physician's global assessment); each rated on a scale from 0 to 3, with higher scores indicating more severe disease. The total Mayo score value ranges from 0 to 12.
Outcome measures
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
n=87 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
n=78 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
n=82 Participants
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
|---|---|---|---|
|
Number of Participants With Clinical Remission at Week 54 and Not Receiving Concomitant Corticosteroids Among Participants on Corticosteroids at Week 0 of Maintenance Study
|
16 Participants
|
22 Participants
|
19 Participants
|
Adverse Events
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
Serious events: 12 serious events
Other events: 88 other events
Deaths: 0 deaths
GLM-I-Rsp-Golimumab 50 mg Maintenance
Serious events: 13 serious events
Other events: 102 other events
Deaths: 0 deaths
GLM-I-Rsp-Golimumab 100 mg Maintenance
Serious events: 22 serious events
Other events: 94 other events
Deaths: 0 deaths
GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg
Serious events: 8 serious events
Other events: 44 other events
Deaths: 0 deaths
GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg
Serious events: 6 serious events
Other events: 15 other events
Deaths: 0 deaths
GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance
Serious events: 7 serious events
Other events: 67 other events
Deaths: 0 deaths
PBO-I-nonRsp-Golimumab 100 mg Maintenance
Serious events: 34 serious events
Other events: 140 other events
Deaths: 0 deaths
GLM-I-nonRsp-Golimumab 100 mg Maintenance
Serious events: 63 serious events
Other events: 247 other events
Deaths: 0 deaths
PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg
Serious events: 7 serious events
Other events: 30 other events
Deaths: 0 deaths
Placebo Extension
Serious events: 8 serious events
Other events: 43 other events
Deaths: 0 deaths
Golimumab 50 mg Extension Phase
Serious events: 11 serious events
Other events: 58 other events
Deaths: 0 deaths
Golimumab 100 mg Extension
Serious events: 91 serious events
Other events: 329 other events
Deaths: 0 deaths
Golimumab 200 mg Extension
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo - 50 mg Extension
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo - Golimumab100 mg Extension
Serious events: 7 serious events
Other events: 19 other events
Deaths: 0 deaths
Golimumab 50 mg - 100 mg Extension
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Golimumab 100 mg - 200 mg Extension
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
n=156 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
n=154 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
n=154 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg
n=76 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg
n=25 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg
n=14 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
|
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance
n=129 participants at risk
Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
PBO-I-nonRsp-Golimumab 100 mg Maintenance
n=230 participants at risk
Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
|
GLM-I-nonRsp-Golimumab 100 mg Maintenance
n=405 participants at risk
Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
|
PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg
n=56 participants at risk
Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
|
Placebo Extension
n=96 participants at risk
Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
|
Golimumab 50 mg Extension Phase
n=93 participants at risk
Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
|
Golimumab 100 mg Extension
n=469 participants at risk
Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
|
Golimumab 200 mg Extension
n=7 participants at risk
Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54.
|
Placebo - 50 mg Extension
n=1 participants at risk
A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.
|
Placebo - Golimumab100 mg Extension
n=28 participants at risk
Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.
|
Golimumab 50 mg - 100 mg Extension
n=19 participants at risk
Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment
|
Golimumab 100 mg - 200 mg Extension
n=10 participants at risk
Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
4.0%
1/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.25%
1/405
|
0.00%
0/56
|
1.0%
1/96
|
1.1%
1/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Anaemia of Chronic Disease
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Aplastic Anaemia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Haemolytic Anaemia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Cardiac disorders
Angina Pectoris
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Cardiac disorders
Cardiac Failure
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
1.0%
1/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
2.1%
2/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Endocrine disorders
Autoimmune Thyroiditis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Eye disorders
Blindness
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Eye disorders
Cataract
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Eye disorders
Macular Fibrosis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal Hernia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Anal Fissure
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
1.9%
3/156
|
1.9%
3/154
|
3.9%
6/154
|
7.9%
6/76
|
12.0%
3/25
|
0.00%
0/14
|
2.3%
3/129
|
5.7%
13/230
|
10.6%
43/405
|
7.1%
4/56
|
1.0%
1/96
|
2.2%
2/93
|
3.8%
18/469
|
0.00%
0/7
|
0.00%
0/1
|
7.1%
2/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Colon Dysplasia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Crohn's Disease
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
4.0%
1/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Large Intestinal Stenosis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Large Intestine Polyp
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.64%
3/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Volvulus of Small Bowel
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Chest Pain
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.64%
3/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Non-Cardiac Chest Pain
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Polyserositis
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Pyrexia
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Hepatobiliary disorders
Bile Duct Stone
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Hepatobiliary disorders
Cholecystitis Chronic
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Hepatobiliary disorders
Drug-Induced Liver Injury
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Abscess Intestinal
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Anal Abscess
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
4.0%
1/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.64%
3/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Appendicitis
|
0.00%
0/156
|
0.00%
0/154
|
1.9%
3/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Bacterial Sepsis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Brain Abscess
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Bronchitis
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
1.8%
1/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Clostridium Difficile Infection
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Cytomegalovirus Infection
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Disseminated Tuberculosis
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Encephalitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Escherichia Pyelonephritis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Extrapulmonary Tuberculosis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Hepatitis A
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Infected Cyst
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Infectious Colitis
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Lobar Pneumonia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Meningitis Viral
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Pelvic Sepsis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Pilonidal Cyst
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Pneumonia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
1.0%
1/96
|
1.1%
1/93
|
1.3%
6/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Pneumonia Legionella
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Postoperative Abscess
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Pulmonary Tuberculosis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Respiratory Tract Infection Viral
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Sepsis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Septic Shock
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Sinusitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Staphylococcal Bacteraemia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Staphylococcal Infection
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Streptococcal Sepsis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Tick-Borne Viral Encephalitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Viral Infection
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
4.0%
1/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Sciatica
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Accidental Poisoning
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Ankle Fracture
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Incisional Hernia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Meniscus Injury
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Penetrating Abdominal Trauma
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Post Procedural Complication
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Spondylopathy Traumatic
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Tendon Rupture
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
1.0%
1/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Thoracic Vertebral Fracture
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
1.0%
1/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Vascular Pseudoaneurysm
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Wrist Fracture
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Investigations
Liver Function Test Abnormal
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Dehydration
|
0.64%
1/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
1.8%
1/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Intervertebral Disc Protrusion
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Seronegative Arthritis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal Adenoma
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Cancer Metastatic
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gallbladder Cancer
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's Disease
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Huerthle Cell Carcinoma
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung Adenocarcinoma
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Cancer
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian Epithelial Cancer
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate Cancer
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Adenocarcinoma
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal Cancer Metastatic
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal Cancer Metastatic
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
T-Cell Lymphoma
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine Leiomyoma
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Carotid Artery Stenosis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Convulsion
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Demyelination
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Facial Paresis
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Loss of Consciousness
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Multiple Sclerosis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Nervous system disorders
Nerve Root Compression
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Syncope
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
1.0%
1/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Psychiatric disorders
Depression
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Psychiatric disorders
Depression Suicidal
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Psychiatric disorders
Depressive Symptom
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Psychiatric disorders
Mental Disorder
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Psychiatric disorders
Substance Abuse
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Renal and urinary disorders
Bladder Neck Obstruction
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
1.0%
1/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Renal and urinary disorders
Pelvi-Ureteric Obstruction
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Benign Prostatic Hyperplasia
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Cervical Dysplasia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Uterine Polyp
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Uterine Prolapse
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Vaginal Prolapse
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial Lung Disease
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
1.8%
1/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity Vasculitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Lichen Sclerosus
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Pyoderma Gangrenosum
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Vascular disorders
Aortic Aneurysm Rupture
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Vascular disorders
Hypertension
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
Other adverse events
| Measure |
Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance
n=156 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance
n=154 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance
n=154 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
|
GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg
n=76 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
|
GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg
n=25 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
|
GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg
n=14 participants at risk
Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
|
Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance
n=129 participants at risk
Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
|
PBO-I-nonRsp-Golimumab 100 mg Maintenance
n=230 participants at risk
Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
|
GLM-I-nonRsp-Golimumab 100 mg Maintenance
n=405 participants at risk
Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
|
PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg
n=56 participants at risk
Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
|
Placebo Extension
n=96 participants at risk
Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
|
Golimumab 50 mg Extension Phase
n=93 participants at risk
Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
|
Golimumab 100 mg Extension
n=469 participants at risk
Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
|
Golimumab 200 mg Extension
n=7 participants at risk
Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54.
|
Placebo - 50 mg Extension
n=1 participants at risk
A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.
|
Placebo - Golimumab100 mg Extension
n=28 participants at risk
Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.
|
Golimumab 50 mg - 100 mg Extension
n=19 participants at risk
Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment
|
Golimumab 100 mg - 200 mg Extension
n=10 participants at risk
Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
2.6%
4/156
|
0.65%
1/154
|
0.65%
1/154
|
0.00%
0/76
|
4.0%
1/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.85%
4/469
|
0.00%
0/7
|
0.00%
0/1
|
10.7%
3/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Drug Eruption
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
1.8%
1/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Eczema
|
1.9%
3/156
|
0.65%
1/154
|
0.65%
1/154
|
1.3%
1/76
|
0.00%
0/25
|
7.1%
1/14
|
1.6%
2/129
|
0.87%
2/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
1.5%
7/469
|
14.3%
1/7
|
0.00%
0/1
|
10.7%
3/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
1/156
|
2.6%
4/154
|
3.2%
5/154
|
2.6%
2/76
|
4.0%
1/25
|
0.00%
0/14
|
1.6%
2/129
|
4.3%
10/230
|
5.4%
22/405
|
1.8%
1/56
|
2.1%
2/96
|
1.1%
1/93
|
4.3%
20/469
|
14.3%
1/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.64%
1/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.87%
2/230
|
0.74%
3/405
|
1.8%
1/56
|
0.00%
0/96
|
2.2%
2/93
|
1.5%
7/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.3%
2/156
|
1.3%
2/154
|
3.2%
5/154
|
0.00%
0/76
|
8.0%
2/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
1.7%
7/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.43%
1/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.85%
4/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Eye disorders
Dry Eye
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Eye disorders
Eye Irritation
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Eye disorders
Myopia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Eye disorders
Ocular Hyperaemia
|
0.64%
1/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Eye disorders
Vision Blurred
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/156
|
0.00%
0/154
|
1.3%
2/154
|
2.6%
2/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.74%
3/405
|
0.00%
0/56
|
1.0%
1/96
|
1.1%
1/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal Pain
|
2.6%
4/156
|
6.5%
10/154
|
7.1%
11/154
|
3.9%
3/76
|
8.0%
2/25
|
0.00%
0/14
|
3.9%
5/129
|
3.9%
9/230
|
5.2%
21/405
|
0.00%
0/56
|
4.2%
4/96
|
6.5%
6/93
|
6.0%
28/469
|
0.00%
0/7
|
100.0%
1/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.64%
1/156
|
2.6%
4/154
|
0.65%
1/154
|
1.3%
1/76
|
0.00%
0/25
|
7.1%
1/14
|
1.6%
2/129
|
0.87%
2/230
|
1.5%
6/405
|
0.00%
0/56
|
1.0%
1/96
|
3.2%
3/93
|
2.3%
11/469
|
0.00%
0/7
|
100.0%
1/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Colitis Ulcerative
|
18.6%
29/156
|
16.2%
25/154
|
11.7%
18/154
|
9.2%
7/76
|
8.0%
2/25
|
7.1%
1/14
|
13.2%
17/129
|
10.9%
25/230
|
12.1%
49/405
|
12.5%
7/56
|
20.8%
20/96
|
18.3%
17/93
|
23.7%
111/469
|
28.6%
2/7
|
0.00%
0/1
|
25.0%
7/28
|
10.5%
2/19
|
30.0%
3/10
|
|
Gastrointestinal disorders
Constipation
|
0.64%
1/156
|
1.3%
2/154
|
1.9%
3/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
1.6%
2/129
|
2.2%
5/230
|
1.5%
6/405
|
0.00%
0/56
|
0.00%
0/96
|
4.3%
4/93
|
2.3%
11/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
5.3%
1/19
|
10.0%
1/10
|
|
Gastrointestinal disorders
Dental Caries
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.25%
1/405
|
1.8%
1/56
|
1.0%
1/96
|
0.00%
0/93
|
0.64%
3/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
4.5%
7/156
|
2.6%
4/154
|
3.2%
5/154
|
5.3%
4/76
|
8.0%
2/25
|
7.1%
1/14
|
1.6%
2/129
|
1.3%
3/230
|
1.7%
7/405
|
1.8%
1/56
|
4.2%
4/96
|
7.5%
7/93
|
6.8%
32/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
20.0%
2/10
|
|
Gastrointestinal disorders
Dyspepsia
|
1.3%
2/156
|
1.9%
3/154
|
1.3%
2/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
2.3%
3/129
|
1.7%
4/230
|
0.49%
2/405
|
1.8%
1/56
|
1.0%
1/96
|
1.1%
1/93
|
3.0%
14/469
|
14.3%
1/7
|
0.00%
0/1
|
3.6%
1/28
|
10.5%
2/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.49%
2/405
|
0.00%
0/56
|
1.0%
1/96
|
0.00%
0/93
|
0.64%
3/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Haematochezia
|
1.3%
2/156
|
0.65%
1/154
|
3.2%
5/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
3.9%
5/129
|
0.43%
1/230
|
0.99%
4/405
|
0.00%
0/56
|
2.1%
2/96
|
3.2%
3/93
|
2.1%
10/469
|
0.00%
0/7
|
100.0%
1/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.3%
2/156
|
1.9%
3/154
|
1.9%
3/154
|
1.3%
1/76
|
4.0%
1/25
|
7.1%
1/14
|
2.3%
3/129
|
1.7%
4/230
|
1.7%
7/405
|
0.00%
0/56
|
2.1%
2/96
|
3.2%
3/93
|
2.8%
13/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/156
|
0.65%
1/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.64%
3/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
1.9%
3/156
|
4.5%
7/154
|
4.5%
7/154
|
1.3%
1/76
|
8.0%
2/25
|
7.1%
1/14
|
4.7%
6/129
|
1.3%
3/230
|
4.0%
16/405
|
1.8%
1/56
|
4.2%
4/96
|
2.2%
2/93
|
4.1%
19/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Gastrointestinal disorders
Vomiting
|
3.2%
5/156
|
1.3%
2/154
|
1.9%
3/154
|
1.3%
1/76
|
4.0%
1/25
|
0.00%
0/14
|
0.78%
1/129
|
0.43%
1/230
|
1.7%
7/405
|
0.00%
0/56
|
3.1%
3/96
|
0.00%
0/93
|
3.2%
15/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
General disorders
Chest Pain
|
0.00%
0/156
|
0.00%
0/154
|
1.3%
2/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.87%
2/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
2.2%
2/93
|
1.3%
6/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
General disorders
Fatigue
|
2.6%
4/156
|
2.6%
4/154
|
3.9%
6/154
|
2.6%
2/76
|
0.00%
0/25
|
0.00%
0/14
|
3.9%
5/129
|
2.6%
6/230
|
0.99%
4/405
|
5.4%
3/56
|
1.0%
1/96
|
2.2%
2/93
|
2.6%
12/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Feeling Cold
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Influenza Like Illness
|
0.64%
1/156
|
1.3%
2/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
2.2%
5/230
|
1.5%
6/405
|
1.8%
1/56
|
1.0%
1/96
|
2.2%
2/93
|
1.3%
6/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
General disorders
Injection Site Erythema
|
0.64%
1/156
|
0.65%
1/154
|
2.6%
4/154
|
3.9%
3/76
|
0.00%
0/25
|
7.1%
1/14
|
0.78%
1/129
|
1.3%
3/230
|
1.2%
5/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
1.5%
7/469
|
14.3%
1/7
|
0.00%
0/1
|
7.1%
2/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Injection Site Induration
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Injection Site Oedema
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Injection Site Rash
|
0.00%
0/156
|
0.65%
1/154
|
1.3%
2/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Oedema Peripheral
|
0.64%
1/156
|
1.9%
3/154
|
2.6%
4/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.87%
2/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
1.3%
6/469
|
14.3%
1/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
General disorders
Pain
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.99%
4/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
General disorders
Pyrexia
|
4.5%
7/156
|
3.9%
6/154
|
1.9%
3/154
|
2.6%
2/76
|
16.0%
4/25
|
7.1%
1/14
|
0.78%
1/129
|
3.9%
9/230
|
4.0%
16/405
|
1.8%
1/56
|
3.1%
3/96
|
7.5%
7/93
|
6.6%
31/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Immune system disorders
Drug Hypersensitivity
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Immune system disorders
Seasonal Allergy
|
1.9%
3/156
|
1.3%
2/154
|
0.65%
1/154
|
1.3%
1/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.99%
4/405
|
1.8%
1/56
|
0.00%
0/96
|
3.2%
3/93
|
2.3%
11/469
|
14.3%
1/7
|
0.00%
0/1
|
3.6%
1/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Infections and infestations
Acute Tonsillitis
|
0.00%
0/156
|
1.3%
2/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Infections and infestations
Bronchitis
|
1.9%
3/156
|
3.9%
6/154
|
0.65%
1/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
1.6%
2/129
|
0.43%
1/230
|
2.5%
10/405
|
3.6%
2/56
|
1.0%
1/96
|
4.3%
4/93
|
4.5%
21/469
|
0.00%
0/7
|
0.00%
0/1
|
10.7%
3/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Chlamydial Infection
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Clostridium Difficile Infection
|
1.3%
2/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.74%
3/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.64%
3/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Conjunctivitis
|
0.64%
1/156
|
0.65%
1/154
|
0.65%
1/154
|
0.00%
0/76
|
4.0%
1/25
|
7.1%
1/14
|
0.00%
0/129
|
1.7%
4/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
3.2%
3/93
|
1.1%
5/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Eyelid Infection
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
1.3%
3/230
|
0.00%
0/405
|
0.00%
0/56
|
1.0%
1/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Infections and infestations
Gastroenteritis
|
1.9%
3/156
|
1.3%
2/154
|
1.9%
3/154
|
2.6%
2/76
|
0.00%
0/25
|
0.00%
0/14
|
1.6%
2/129
|
1.7%
4/230
|
0.99%
4/405
|
1.8%
1/56
|
0.00%
0/96
|
5.4%
5/93
|
4.9%
23/469
|
0.00%
0/7
|
0.00%
0/1
|
7.1%
2/28
|
0.00%
0/19
|
20.0%
2/10
|
|
Infections and infestations
Gastroenteritis Viral
|
0.00%
0/156
|
1.3%
2/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
1.6%
2/129
|
1.3%
3/230
|
0.99%
4/405
|
0.00%
0/56
|
0.00%
0/96
|
2.2%
2/93
|
1.7%
8/469
|
28.6%
2/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Giardiasis
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Infections and infestations
Herpes Zoster
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
1.7%
4/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
3.0%
14/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Infections and infestations
Hordeolum
|
0.64%
1/156
|
1.3%
2/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
1.6%
2/129
|
1.3%
3/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
1.1%
5/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Influenza
|
2.6%
4/156
|
4.5%
7/154
|
1.3%
2/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
5.4%
7/129
|
3.0%
7/230
|
2.5%
10/405
|
1.8%
1/56
|
3.1%
3/96
|
9.7%
9/93
|
7.9%
37/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Labyrinthitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Nasopharyngitis
|
6.4%
10/156
|
9.1%
14/154
|
14.9%
23/154
|
9.2%
7/76
|
16.0%
4/25
|
21.4%
3/14
|
3.9%
5/129
|
7.4%
17/230
|
8.1%
33/405
|
5.4%
3/56
|
5.2%
5/96
|
10.8%
10/93
|
16.4%
77/469
|
28.6%
2/7
|
100.0%
1/1
|
14.3%
4/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Infections and infestations
Oral Herpes
|
1.9%
3/156
|
1.3%
2/154
|
1.3%
2/154
|
2.6%
2/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
1.3%
3/230
|
1.5%
6/405
|
1.8%
1/56
|
1.0%
1/96
|
1.1%
1/93
|
4.5%
21/469
|
14.3%
1/7
|
0.00%
0/1
|
7.1%
2/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Infections and infestations
Paronychia
|
0.00%
0/156
|
0.65%
1/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Pharyngitis
|
2.6%
4/156
|
4.5%
7/154
|
3.2%
5/154
|
2.6%
2/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
3.0%
7/230
|
1.5%
6/405
|
0.00%
0/56
|
1.0%
1/96
|
6.5%
6/93
|
4.9%
23/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Infections and infestations
Sinusitis
|
1.9%
3/156
|
3.9%
6/154
|
3.9%
6/154
|
1.3%
1/76
|
4.0%
1/25
|
0.00%
0/14
|
2.3%
3/129
|
2.2%
5/230
|
2.2%
9/405
|
1.8%
1/56
|
3.1%
3/96
|
5.4%
5/93
|
9.0%
42/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Skin Infection
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.43%
2/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Tinea Cruris
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.43%
1/230
|
0.25%
1/405
|
1.8%
1/56
|
1.0%
1/96
|
2.2%
2/93
|
0.85%
4/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
8.0%
2/25
|
0.00%
0/14
|
0.78%
1/129
|
0.43%
1/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
1.1%
5/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
2.6%
4/156
|
5.2%
8/154
|
5.2%
8/154
|
7.9%
6/76
|
12.0%
3/25
|
7.1%
1/14
|
4.7%
6/129
|
7.0%
16/230
|
4.9%
20/405
|
7.1%
4/56
|
4.2%
4/96
|
6.5%
6/93
|
8.3%
39/469
|
14.3%
1/7
|
0.00%
0/1
|
7.1%
2/28
|
10.5%
2/19
|
20.0%
2/10
|
|
Infections and infestations
Urinary Tract Infection
|
2.6%
4/156
|
1.9%
3/154
|
0.65%
1/154
|
2.6%
2/76
|
0.00%
0/25
|
7.1%
1/14
|
3.1%
4/129
|
0.87%
2/230
|
0.49%
2/405
|
1.8%
1/56
|
2.1%
2/96
|
2.2%
2/93
|
3.0%
14/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Infections and infestations
Viral Infection
|
0.00%
0/156
|
1.3%
2/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
1.3%
3/230
|
0.99%
4/405
|
3.6%
2/56
|
2.1%
2/96
|
3.2%
3/93
|
1.9%
9/469
|
14.3%
1/7
|
0.00%
0/1
|
3.6%
1/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Infections and infestations
Viral Pharyngitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
1.3%
1/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.00%
0/156
|
0.65%
1/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
14.3%
2/14
|
0.00%
0/129
|
1.7%
4/230
|
0.99%
4/405
|
0.00%
0/56
|
1.0%
1/96
|
1.1%
1/93
|
2.3%
11/469
|
28.6%
2/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Infections and infestations
Vulvovaginal Candidiasis
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.87%
2/230
|
0.25%
1/405
|
1.8%
1/56
|
0.00%
0/96
|
1.1%
1/93
|
0.85%
4/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Infections and infestations
Vulvovaginal Mycotic Infection
|
0.64%
1/156
|
1.9%
3/154
|
0.65%
1/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.85%
4/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Animal Bite
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
1.3%
2/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
2.2%
2/93
|
0.64%
3/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Bite
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
100.0%
1/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Hand Fracture
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/156
|
0.00%
0/154
|
1.3%
2/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Ligament Sprain
|
1.3%
2/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.74%
3/405
|
0.00%
0/56
|
2.1%
2/96
|
0.00%
0/93
|
1.1%
5/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Limb Fracture
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Toxicity to Various Agents
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Investigations
Alanine Aminotransferase Increased
|
0.64%
1/156
|
1.9%
3/154
|
1.9%
3/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
2.3%
3/129
|
2.6%
6/230
|
1.5%
6/405
|
0.00%
0/56
|
0.00%
0/96
|
2.2%
2/93
|
1.5%
7/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.64%
1/156
|
3.2%
5/154
|
1.3%
2/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
1.6%
2/129
|
0.87%
2/230
|
0.99%
4/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
1.3%
6/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Investigations
Blood Calcium Increased
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Investigations
Blood Creatinine Increased
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
0.43%
2/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Investigations
Blood Parathyroid Hormone Increased
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Investigations
Haemoglobin Decreased
|
0.64%
1/156
|
0.65%
1/154
|
0.00%
0/154
|
2.6%
2/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
1.8%
1/56
|
0.00%
0/96
|
0.00%
0/93
|
0.85%
4/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Investigations
Neutrophil Count Increased
|
0.00%
0/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Investigations
Vitamin D Decreased
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Investigations
White Blood Cell Count Increased
|
0.00%
0/156
|
1.3%
2/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.43%
1/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/156
|
0.00%
0/154
|
1.3%
2/154
|
1.3%
1/76
|
4.0%
1/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.25%
1/405
|
1.8%
1/56
|
1.0%
1/96
|
1.1%
1/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
11/156
|
7.1%
11/154
|
5.8%
9/154
|
9.2%
7/76
|
0.00%
0/25
|
7.1%
1/14
|
5.4%
7/129
|
4.8%
11/230
|
7.2%
29/405
|
3.6%
2/56
|
5.2%
5/96
|
9.7%
9/93
|
5.1%
24/469
|
0.00%
0/7
|
0.00%
0/1
|
10.7%
3/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.6%
4/156
|
1.9%
3/154
|
4.5%
7/154
|
1.3%
1/76
|
0.00%
0/25
|
7.1%
1/14
|
3.9%
5/129
|
2.6%
6/230
|
2.5%
10/405
|
1.8%
1/56
|
1.0%
1/96
|
2.2%
2/93
|
6.4%
30/469
|
0.00%
0/7
|
0.00%
0/1
|
7.1%
2/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
1.3%
3/230
|
0.99%
4/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.64%
3/469
|
14.3%
1/7
|
0.00%
0/1
|
7.1%
2/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
2.6%
4/156
|
1.9%
3/154
|
0.65%
1/154
|
1.3%
1/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
2.2%
5/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
1.5%
7/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Rotator Cuff Syndrome
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Spinal Osteoarthritis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Demyelination
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
9.0%
14/156
|
8.4%
13/154
|
7.8%
12/154
|
10.5%
8/76
|
8.0%
2/25
|
14.3%
2/14
|
4.7%
6/129
|
9.6%
22/230
|
6.2%
25/405
|
5.4%
3/56
|
1.0%
1/96
|
6.5%
6/93
|
7.7%
36/469
|
14.3%
1/7
|
100.0%
1/1
|
7.1%
2/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Nervous system disorders
Migraine
|
0.64%
1/156
|
1.9%
3/154
|
0.00%
0/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
1.7%
4/230
|
0.25%
1/405
|
1.8%
1/56
|
1.0%
1/96
|
0.00%
0/93
|
0.43%
2/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Psychiatric disorders
Anxiety
|
0.64%
1/156
|
1.3%
2/154
|
1.3%
2/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
1.6%
2/129
|
0.87%
2/230
|
0.74%
3/405
|
0.00%
0/56
|
2.1%
2/96
|
0.00%
0/93
|
2.6%
12/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Psychiatric disorders
Depression
|
0.64%
1/156
|
1.9%
3/154
|
1.9%
3/154
|
1.3%
1/76
|
0.00%
0/25
|
7.1%
1/14
|
3.1%
4/129
|
0.00%
0/230
|
1.2%
5/405
|
1.8%
1/56
|
0.00%
0/96
|
1.1%
1/93
|
2.1%
10/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Psychiatric disorders
Insomnia
|
1.3%
2/156
|
0.65%
1/154
|
1.3%
2/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
1.6%
2/129
|
2.2%
5/230
|
2.5%
10/405
|
1.8%
1/56
|
2.1%
2/96
|
1.1%
1/93
|
1.7%
8/469
|
14.3%
1/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/156
|
0.00%
0/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.43%
1/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Renal and urinary disorders
Micturition Urgency
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.87%
2/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Renal and urinary disorders
Renal Colic
|
0.00%
0/156
|
0.65%
1/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
3.6%
1/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Cervix Haemorrhage Uterine
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.2%
5/156
|
3.2%
5/154
|
5.2%
8/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
3.9%
5/129
|
4.3%
10/230
|
4.4%
18/405
|
3.6%
2/56
|
8.3%
8/96
|
4.3%
4/93
|
7.7%
36/469
|
0.00%
0/7
|
0.00%
0/1
|
7.1%
2/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/156
|
0.65%
1/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.87%
2/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
1.5%
7/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.78%
1/129
|
0.87%
2/230
|
0.74%
3/405
|
0.00%
0/56
|
0.00%
0/96
|
1.1%
1/93
|
1.9%
9/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.64%
1/156
|
1.9%
3/154
|
3.9%
6/154
|
0.00%
0/76
|
4.0%
1/25
|
0.00%
0/14
|
0.00%
0/129
|
1.3%
3/230
|
2.5%
10/405
|
1.8%
1/56
|
0.00%
0/96
|
4.3%
4/93
|
4.1%
19/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
1.3%
2/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.43%
1/230
|
0.25%
1/405
|
0.00%
0/56
|
1.0%
1/96
|
0.00%
0/93
|
0.64%
3/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.3%
2/156
|
1.3%
2/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
7.1%
1/14
|
0.00%
0/129
|
0.43%
1/230
|
0.49%
2/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
1.5%
7/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
3/156
|
0.00%
0/154
|
2.6%
4/154
|
1.3%
1/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
0.87%
2/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
2.2%
2/93
|
0.85%
4/469
|
0.00%
0/7
|
0.00%
0/1
|
7.1%
2/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.64%
1/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Dermal Cyst
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.21%
1/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.9%
3/156
|
5.8%
9/154
|
3.9%
6/154
|
1.3%
1/76
|
0.00%
0/25
|
7.1%
1/14
|
1.6%
2/129
|
3.0%
7/230
|
2.7%
11/405
|
3.6%
2/56
|
1.0%
1/96
|
3.2%
3/93
|
3.4%
16/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
5.3%
1/19
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Vascular disorders
Hot Flush
|
0.64%
1/156
|
0.65%
1/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.00%
0/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.00%
0/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Vascular disorders
Hypertension
|
2.6%
4/156
|
0.65%
1/154
|
0.65%
1/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.78%
1/129
|
2.2%
5/230
|
2.7%
11/405
|
3.6%
2/56
|
0.00%
0/96
|
3.2%
3/93
|
2.6%
12/469
|
0.00%
0/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
10.0%
1/10
|
|
Vascular disorders
Phlebitis
|
0.00%
0/156
|
0.00%
0/154
|
0.00%
0/154
|
0.00%
0/76
|
0.00%
0/25
|
0.00%
0/14
|
0.00%
0/129
|
0.00%
0/230
|
0.25%
1/405
|
0.00%
0/56
|
0.00%
0/96
|
0.00%
0/93
|
0.43%
2/469
|
14.3%
1/7
|
0.00%
0/1
|
0.00%
0/28
|
0.00%
0/19
|
0.00%
0/10
|
Additional Information
Senior Director
Janssen Research & Development
Phone: 215-793-7540
Results disclosure agreements
- Principal investigator is a sponsor employee 12 months after study ends, sponsor will be provided with a copy of the materials at least 45 days prior to submission, with details of proposed date, journal or conference name of publication \& it will have 30 days post receipt to send a written request that the publication be delayed on the basis it exposes intellectual property that requires propriety protection but it will be only for 60 days after which investigator will be free to publish. The participation of sponsor will be acknowledged.
- Publication restrictions are in place
Restriction type: OTHER