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Trial Outcomes & Findings for Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. (NCT NCT04625725)

NCT ID: NCT04625725

Last Updated: 2024-12-31

Results Overview

To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 prior to Day 183. Planned to be evaluated through Day 183, however, the number of events required for the primary endpoint was achieved 165 days after the study start date which is displayed in the primary efficacy row below. Final analysis is final data from the study based on the pre-planned 183 days of follow up for this endpoint.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

5197 participants

Primary outcome timeframe

165 Days for primary analysis, 183 days for final analysis

Results posted on

2024-12-31

Participant Flow

Participant milestones

Participant milestones
Measure
AZD7442
300 mg (AZD8895 and AZD1061)
Placebo
Saline Placebo
Group1
2 doses of AZD7442 300mg, 10-14 months schedule
Group 2
2 doses ofAZD7442 300mg, 6 month schedule
Group 3a
2 doses of AZD7442 300mg, 10-14 months schedule + 2 doses of AZD7442 600mg, 6 month schedule;
Group 3b
1 dose of AZD7442 300mg, 6 month schedule + 2 doses of AZD7442 600mg, 6 month schedule
Provent Main Study
STARTED
3460
1737
0
0
0
0
Provent Main Study
COMPLETED
2490
1179
0
0
0
0
Provent Main Study
NOT COMPLETED
970
558
0
0
0
0
Provent Sub Study
STARTED
0
0
234
119
76
74
Provent Sub Study
COMPLETED
0
0
194
90
64
61
Provent Sub Study
NOT COMPLETED
0
0
40
29
12
13

Reasons for withdrawal

Reasons for withdrawal
Measure
AZD7442
300 mg (AZD8895 and AZD1061)
Placebo
Saline Placebo
Group1
2 doses of AZD7442 300mg, 10-14 months schedule
Group 2
2 doses ofAZD7442 300mg, 6 month schedule
Group 3a
2 doses of AZD7442 300mg, 10-14 months schedule + 2 doses of AZD7442 600mg, 6 month schedule;
Group 3b
1 dose of AZD7442 300mg, 6 month schedule + 2 doses of AZD7442 600mg, 6 month schedule
Provent Main Study
PARTICIPANT NOT FULFILLING INCLUSION CRITERIA
1
0
0
0
0
0
Provent Main Study
Withdrawal by Subject
242
144
0
0
0
0
Provent Main Study
Physician Decision
5
0
0
0
0
0
Provent Main Study
Protocol Violation
1
0
0
0
0
0
Provent Main Study
Lost to Follow-up
357
200
0
0
0
0
Provent Main Study
Death
22
10
0
0
0
0
Provent Main Study
Adverse Event
2
1
0
0
0
0
Provent Main Study
Participants dosed in sub-study
310
193
0
0
0
0
Provent Main Study
PARTICIPANT NOT COMPLIANT
1
1
0
0
0
0
Provent Main Study
PARTICIPANT COULD NOT BE REACHED PRIOR TO DBL
14
2
0
0
0
0
Provent Main Study
INCARCERATION
3
0
0
0
0
0
Provent Main Study
WITHDRAWAL OF CONSENT
3
2
0
0
0
0
Provent Main Study
MOVED ABROAD / LOCATION
7
2
0
0
0
0
Provent Main Study
PARTICIPANT DID NOT ATTEND VISIT
2
2
0
0
0
0
Provent Main Study
MISSING REASON
0
1
0
0
0
0
Provent Sub Study
SUBJECT MOVED OUT OF AREA
0
0
0
1
0
0
Provent Sub Study
SUBJECT WAS MOVING AWAY FROM THE STUDY CLINIC
0
0
1
0
0
0
Provent Sub Study
Lost to Follow-up
0
0
20
10
6
4
Provent Sub Study
Death
0
0
8
5
0
1
Provent Sub Study
Adverse Event
0
0
0
0
0
1
Provent Sub Study
DUE TO SUBJECT'S DECLINING HEALTH THE SUBJECT WILL NO LONGER BE ABLE TO PARTICIPATE IN THE STUDY
0
0
0
0
1
0
Provent Sub Study
Withdrawal by Subject
0
0
11
13
5
6
Provent Sub Study
NON COMPLIANCE BY SUBJECT
0
0
0
0
0
1

Baseline Characteristics

This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
AZD7442
n=3460 Participants
300 mg (AZD8895 and AZD1061)
Placebo
n=1737 Participants
Saline Placebo
Group 1
n=234 Participants
2 doses of AZD7442 300mg, 10-14 months schedule
Group 2
n=119 Participants
2 doses ofAZD7442 300mg, 6 month schedule
Group 3a
n=76 Participants
2 doses of AZD7442 300mg, 10-14 months schedule + 2 doses of AZD7442 600mg, 6 month schedule
Group 3b
n=74 Participants
1 dose of AZD7442 300mg, 6 month schedule + 2 doses of AZD7442 600mg, 6 month schedule
Total
n=5700 Participants
Total of all reporting groups
Age, Continuous
Main Study
57 Years
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
57 Years
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
—
—
—
—
57 Years
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Age, Continuous
Sub Study
—
—
62.0 Years
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
62.0 Years
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
60.5 Years
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
61 Years
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
62 Years
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Age, Customized
Main Study : >= 18 - < 60 years
1960 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
980 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
—
—
—
—
2940 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Age, Customized
Main Study : >= 60 - < 70 years
1083 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
563 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
—
—
—
—
1646 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Age, Customized
Main Study : >= 70 - < 80 years
368 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
174 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
—
—
—
—
542 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Age, Customized
Main Study : >= 80 years
49 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
20 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
—
—
—
—
69 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Age, Customized
Sub Study : >= 18 - < 60 years
—
—
82 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
37 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
31 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
33 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
183 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Age, Customized
Sub Study : >= 60 - < 70 years
—
—
103 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
58 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
33 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
30 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
224 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Age, Customized
Sub Study : >= 70 - < 80 years
—
—
44 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
21 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
8 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
10 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
83 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Age, Customized
Sub Study : >= 80 years
—
—
5 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
3 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
4 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
1 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
13 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Sex: Female, Male
Main Study · Female
1594 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
802 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
—
—
—
—
2396 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Sex: Female, Male
Main Study · Male
1866 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
935 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
—
—
—
—
2801 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Sex: Female, Male
Sub Study · Female
—
—
113 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
48 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
33 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
35 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
229 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Sex: Female, Male
Sub Study · Male
—
—
121 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
71 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
43 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
39 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
274 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Race/Ethnicity, Customized
Main Study · Hispanic or Latino
539 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
215 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
—
—
—
—
754 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Race/Ethnicity, Customized
Main Study · Not Hispanic or Latino
2731 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
1412 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
—
—
—
—
4143 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Race/Ethnicity, Customized
Main Study · Not reported
89 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
56 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
145 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Main Study · Unknown
79 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
42 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
121 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Sub Study · Hispanic or Latino
—
—
31 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
6 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
9 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
12 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
58 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Race/Ethnicity, Customized
Sub Study · Not Hispanic or Latino
—
—
192 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
109 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
61 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
56 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
418 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable.
Race/Ethnicity, Customized
Sub Study · Not reported
—
—
2 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
3 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Sub Study · Unknown
—
—
4 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
4 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
3 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
12 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Main Study · White
2545 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1249 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
3794 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Main Study · Black or African American
597 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
302 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
899 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Main Study · Asian
110 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
60 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
170 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Main Study · American Indian or Alaska Native
19 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
10 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
29 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Main Study · Native Hawaiian or Other Pacific Islander
4 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
4 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
8 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Main Study · Other
15 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
12 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
27 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Main Study · Missing
2 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
2 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
4 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Sub Study · White
—
—
204 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
106 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
52 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
53 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
415 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Sub Study · Black or African American
—
—
20 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
11 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
14 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
14 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
59 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Sub Study · Asian
—
—
4 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
6 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
12 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Sub Study · American Indian or Alaska Native
—
—
0 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Sub Study · Native Hawaiian or Other Pacific Islander
—
—
0 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Sub Study · Other
—
—
0 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
2 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
2 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Race/Ethnicity, Customized
Sub Study · Missing
—
—
0 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
SARS-CoV-2 status at baseline
Main Study · Positive
19 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
6 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
25 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
SARS-CoV-2 status at baseline
Main Study · Negative
3316 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1665 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
4981 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
SARS-CoV-2 status at baseline
Main Study · Missing
125 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
66 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
191 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
SARS-CoV-2 status at baseline
Sub Study · Positive
—
—
0 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
2 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
SARS-CoV-2 status at baseline
Sub Study · Negative
—
—
229 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
114 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
75 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
70 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
488 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
SARS-CoV-2 status at baseline
Sub Study · Missing
—
—
5 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
4 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
3 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
13 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Region
Main Study · North America
2487 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1232 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
3719 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Region
Main Study · United Kingdom
611 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
312 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
923 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Region
Main Study · European Union
362 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
193 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
555 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Region
Sub Study · North America
—
—
130 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
75 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
76 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
74 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
355 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Region
Sub Study · United Kingdom
—
—
77 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
27 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
104 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Region
Sub Study · European Union
—
—
27 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
17 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
0 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
44 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Any COVID-19 comorbidities at baseline
Main Study · Yes
2432 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1206 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
3638 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Any COVID-19 comorbidities at baseline
Main Study · Missing
1028 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
531 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
1559 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Any COVID-19 comorbidities at baseline
Sub Study · Yes
—
—
192 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
97 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
66 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
68 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
423 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Any COVID-19 comorbidities at baseline
Sub Study · Missing
—
—
42 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
22 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
10 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
6 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
80 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Any high risk for severe COVID-19 at baseline
Main Study · Yes
2674 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1366 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
4040 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Any high risk for severe COVID-19 at baseline
Main Study · Missing
786 Participants
n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
371 Participants
n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
1157 Participants
n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Any high risk for severe COVID-19 at baseline
Sub Study · Yes
—
—
209 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
107 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
69 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
73 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
458 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Any high risk for severe COVID-19 at baseline
Sub Study · Missing
—
—
25 Participants
n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
12 Participants
n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
7 Participants
n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
1 Participants
n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
45 Participants
n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Height
Main Study
170.04 cm
STANDARD_DEVIATION 10.10 • n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
170.17 cm
STANDARD_DEVIATION 9.84 • n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
170.9 cm
STANDARD_DEVIATION 10.02 • n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Height
Sub Study
—
—
170.03 cm
STANDARD_DEVIATION 10.29 • n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
171.25 cm
STANDARD_DEVIATION 10.06 • n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
169.03 cm
STANDARD_DEVIATION 9.76 • n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
168.72 cm
STANDARD_DEVIATION 10.27 • n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
169.97 cm
STANDARD_DEVIATION 10.16 • n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Baseline BMI
Main Study
29.57 kg/m**2
STANDARD_DEVIATION 6.88 • n=3460 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
29.62 kg/m**2
STANDARD_DEVIATION 6.98 • n=1737 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
—
—
—
—
29.59 kg/m**2
STANDARD_DEVIATION 6.91 • n=5197 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
Baseline BMI
Sub Study
—
—
29.72 kg/m**2
STANDARD_DEVIATION 6.00 • n=234 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
28.88 kg/m**2
STANDARD_DEVIATION 6.31 • n=119 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
29.67 kg/m**2
STANDARD_DEVIATION 7.06 • n=76 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
31.50 kg/m**2
STANDARD_DEVIATION 7.06 • n=74 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable
29.78 kg/m**2
STANDARD_DEVIATION 6.43 • n=503 Participants • This study is made of two parts: Main study (overall number of participants is 5197) and a Sub Study where 503 participants from the Main study were allocated to different treatments with respect to the Main Study. Total across groups is not applicable

PRIMARY outcome

Timeframe: 165 Days for primary analysis, 183 days for final analysis

Population: All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection.

To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19 prior to Day 183. Planned to be evaluated through Day 183, however, the number of events required for the primary endpoint was achieved 165 days after the study start date which is displayed in the primary efficacy row below. Final analysis is final data from the study based on the pre-planned 183 days of follow up for this endpoint.

Outcome measures

Outcome measures
Measure
AZD7442
n=3441 Participants
300 mg (AZD8895 and AZD1061)
Placebo
n=1731 Participants
Saline placebo
Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness
Primary Analysis
8 Participants
17 Participants
Number of Participants With First Case of SARS-CoV-2 RT-PCR-positive Symptomatic Illness
Final Analysis
12 Participants
34 Participants

PRIMARY outcome

Timeframe: 457 Days, Final analysis

Population: All participants dosed

To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo

Outcome measures

Outcome measures
Measure
AZD7442
n=3461 Participants
300 mg (AZD8895 and AZD1061)
Placebo
n=1736 Participants
Saline placebo
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Adverse Events
2016 Participants
1007 Participants
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Serious Adverse Events
215 Participants
97 Participants
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Medically Attended Adverse Events
991 Participants
439 Participants
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP
Adverse Events of Special Interest
103 Participants
43 Participants

SECONDARY outcome

Timeframe: 366 days

Population: All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection and had an evaluable sample obtained.

To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of SARS-CoV-2 infection

Outcome measures

Outcome measures
Measure
AZD7442
n=3121 Participants
300 mg (AZD8895 and AZD1061)
Placebo
n=1563 Participants
Saline placebo
The Incidence of Participants Who Have a Post-treatment Response (Negative at Baseline to Positive at Any Time Post-baseline) for SARS-CoV-2 Nucleocapsid Antibodies.
198 Participants
139 Participants

SECONDARY outcome

Timeframe: 366 Days

Population: All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection

To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of severe or critical symptomatic COVID-19

Outcome measures

Outcome measures
Measure
AZD7442
n=3441 Participants
300 mg (AZD8895 and AZD1061)
Placebo
n=1731 Participants
Saline placebo
The Incidence of SARS-CoV-2 RT-PCR-positive Severe or Critical Symptomatic Illness Occurring After Dosing With IMP
2 Participants
11 Participants

SECONDARY outcome

Timeframe: 366 days

Population: All randomized and dosed participants who did not have a prior SARS-CoV-2 RT-PCR-positive confirmed COVID-19 infection

To estimate the efficacy of a single IM dose of AZD7442 compared to placebo for the prevention of COVID-19-related Emergency Department visits

Outcome measures

Outcome measures
Measure
AZD7442
n=3441 Participants
300 mg (AZD8895 and AZD1061)
Placebo
n=1731 Participants
Saline placebo
The Incidence of COVID-19-related Emergency Department Visits Occurring After Dosing With IMP
8 Participants
8 Participants

SECONDARY outcome

Timeframe: 457 days

Population: PK analysis set (only AZD7442 arm)

To assess the pharmacokinetics of AZD7442 administered as a single dose of 300 mg IM

Outcome measures

Outcome measures
Measure
AZD7442
n=3290 Participants
300 mg (AZD8895 and AZD1061)
Placebo
Saline placebo
Serum AZD7442 Concentrations, PK Parameters if Data Permit.
Day 8
18.667 µg/mL
Geometric Coefficient of Variation 92.947
—
Serum AZD7442 Concentrations, PK Parameters if Data Permit.
Day 29
22.602 µg/mL
Geometric Coefficient of Variation 64.691
—
Serum AZD7442 Concentrations, PK Parameters if Data Permit.
Day 58
18.707 µg/mL
Geometric Coefficient of Variation 65.981
—
Serum AZD7442 Concentrations, PK Parameters if Data Permit.
Day 92
14.037 µg/mL
Geometric Coefficient of Variation 67.922
—
Serum AZD7442 Concentrations, PK Parameters if Data Permit.
Day 183
5.593 µg/mL
Geometric Coefficient of Variation 83.580
—
Serum AZD7442 Concentrations, PK Parameters if Data Permit.
Day 366
1.340 µg/mL
Geometric Coefficient of Variation 90.132
—
Serum AZD7442 Concentrations, PK Parameters if Data Permit.
Day 457
0.565 µg/mL
Geometric Coefficient of Variation 85.733
—

SECONDARY outcome

Timeframe: 457 days

Population: AZD7442 ADA Evaluable Analysis Set

To evaluate ADA responses to AZD7442 in serum

Outcome measures

Outcome measures
Measure
AZD7442
n=3086 Participants
300 mg (AZD8895 and AZD1061)
Placebo
n=1540 Participants
Saline placebo
Incidence of ADA to AZD7442 in Serum
403 Participants
34 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 165 Days

Population: All participants dosed

To assess the safety and tolerability of a single IM dose of AZD7442 compared to placebo

Outcome measures

Outcome measures
Measure
AZD7442
n=3461 Participants
300 mg (AZD8895 and AZD1061)
Placebo
n=1736 Participants
Saline placebo
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis
Adverse Events
1221 Participants
593 Participants
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis
Serious Adverse Events
50 Participants
23 Participants
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis
Medically Attended Adverse Events
360 Participants
157 Participants
AEs, SAEs, MAAEs, and AESIs Post Dose of IMP at Time of Primary Efficacy Analysis
Adverse Events of Special Interest
93 Participants
37 Participants

Adverse Events

AZD7442

Serious events: 215 serious events
Other events: 1988 other events
Deaths: 22 deaths

Placebo

Serious events: 97 serious events
Other events: 993 other events
Deaths: 10 deaths

Group 1

Serious events: 31 serious events
Other events: 185 other events
Deaths: 8 deaths

Group 2

Serious events: 20 serious events
Other events: 94 other events
Deaths: 5 deaths

Group 3a

Serious events: 12 serious events
Other events: 58 other events
Deaths: 0 deaths

Group 3b

Serious events: 12 serious events
Other events: 55 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
AZD7442
n=3461 participants at risk
Description (Arm-group)
Placebo
n=1736 participants at risk
Description (Arm-group)
Group 1
n=234 participants at risk
Description (Arm-group)
Group 2
n=119 participants at risk
Description (Arm-group)
Group 3a
n=76 participants at risk
Description (Arm-group)
Group 3b
n=74 participants at risk
Description (Arm-group)
Gastrointestinal disorders
Melaena
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Spondylolisthesis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adrenal gland cancer metastatic
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cervix carcinoma recurrent
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholangiocarcinoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Chronic myeloid leukaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer stage iv
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
External ear neoplasm malignant
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer metastatic
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma recurrent
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma stage iii
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of unknown primary site
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma benign
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma recurrent
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papillary renal cell carcinoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of lung
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Amyotrophic lateral sclerosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Bell's palsy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Carotid artery disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Carotid artery stenosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebellar infarction
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral haemorrhage
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral infarction
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral ischaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral venous sinus thrombosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebrovascular accident
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Inner ear disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Complex regional pain syndrome
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Dementia alzheimer's type
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Dizziness
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Epilepsy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Generalised tonic-clonic seizure
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Haemorrhage intracranial
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Haemorrhagic stroke
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Hepatic encephalopathy
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Intracranial aneurysm
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Ischaemic stroke
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Lacunar infarction
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Lumbar radiculopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Metabolic encephalopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Migraine
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Neuropathy peripheral
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Presyncope
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Ruptured cerebral aneurysm
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Seizure
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Simple partial seizures
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Syncope
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Thalamic infarction
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Toxic encephalopathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Transient ischaemic attack
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Product Issues
Device deposit issue
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Alcohol abuse
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Bipolar disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Depression
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Major depression
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Mental status changes
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Psychiatric decompensation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Suicidal ideation
0.06%
2/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Acute kidney injury
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Chronic kidney disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
End stage renal disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Haematuria
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Hydronephrosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Nephrolithiasis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Pelvi-ureteric obstruction
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Renal failure
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Subcapsular renal haematoma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Urinary retention
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Hypothyroidism
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Intermenstrual bleeding
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Vaginal haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Asthma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Thyrotoxic crisis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pneumothorax
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Respiratory alkalosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Diabetic foot
0.09%
3/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Drug eruption
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Social circumstances
Sexual abuse
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Surgical and medical procedures
Withdrawal of life support
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Aortic aneurysm
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Deep vein thrombosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hypertension
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hypertensive crisis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hypertensive urgency
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hypotension
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Peripheral arterial occlusive disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Secondary hypertension
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Shock haemorrhagic
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Leukocytosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Retinal detachment
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal distension
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal hernia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal pain
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal pain upper
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Anaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Colitis
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Diarrhoea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Diarrhoea haemorrhagic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Enterovesical fistula
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gallstone ileus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastric ulcer
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastritis
0.06%
2/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastrointestinal ulcer haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Haemorrhoids
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Hiatus hernia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Ileus
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Ileus paralytic
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Intestinal ischaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Intra-abdominal fluid collection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Irritable bowel syndrome
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Mesenteric artery thrombosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oesophageal haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Anaemia of chronic disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oesophagitis haemorrhagic
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Overflow diarrhoea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Pancreatitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Pancreatitis acute
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Pancreatitis chronic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Pancreatitis relapsing
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Peritoneal cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Salivary gland mass
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Small intestinal obstruction
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Volvulus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Vomiting
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Asthenia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Acute left ventricular failure
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Chest pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Death
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Acute myocardial infarction
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Fatigue
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Angina pectoris
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Angina unstable
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Multiple organ dysfunction syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Non-cardiac chest pain
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Oedema peripheral
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Arrhythmia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Biliary obstruction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Cholecystitis
0.12%
4/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Cholecystitis acute
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Cholelithiasis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Gallbladder obstruction
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatic cirrhosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatic cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatic failure
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Arteriosclerosis coronary artery
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatitis acute
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Atrial fibrillation
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Abdominal abscess
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Abscess limb
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Appendicitis
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Appendicitis perforated
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Arteriovenous graft site infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Bacteraemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Atrioventricular block complete
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Bronchitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Covid-19
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Covid-19 pneumonia
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.2%
20/1736 • Number of events 20 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Campylobacter infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Catheter site infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Cellulitis
0.17%
6/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Clostridium difficile colitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Atrioventricular block second degree
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Cystitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Device related infection
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Diverticulitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Endocarditis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Enterococcal bacteraemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Extradural abscess
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Bradycardia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gangrene
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gastroenteritis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gastroenteritis viral
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Hepatitis e
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Incision site cellulitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiac arrest
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Influenza
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiac failure
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Localised infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Lower respiratory tract infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Lung abscess
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiac failure acute
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Meningitis streptococcal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Diabetes mellitus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiac failure congestive
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Necrotising fasciitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardio-respiratory arrest
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Osteomyelitis
0.09%
3/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiogenic shock
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Peritonitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumococcal bacteraemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumonia
0.20%
7/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiomegaly
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumonia bacterial
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumonia fungal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumonia pneumococcal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumonia viral
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Postoperative wound infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiomyopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pulmonary sepsis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Secondary syphilis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Sepsis
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Septic shock
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Sialoadenitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Coronary artery disease
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Soft tissue infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Staphylococcal infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Subcutaneous abscess
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Tonsillitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Coronary artery stenosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Urinary tract infection
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Urosepsis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Vestibular neuronitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Viral diarrhoea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Wound infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Accidental overdose
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Ankle fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Cervical vertebral fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Concussion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Fall
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Femoral neck fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Femur fracture
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Fibula fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Foot fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Gun shot wound
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Humerus fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Incisional hernia, obstructive
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Left ventricular failure
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Joint injury
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Limb injury
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Multiple fractures
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Multiple injuries
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Mitral valve disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Overdose
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Patella fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Peritoneal dialysis complication
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Procedural pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Radius fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Rib fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Road traffic accident
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Second degree chemical burn of skin
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Skin abrasion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Skin laceration
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Myocardial infarction
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Sternal fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Subdural haemorrhage
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Tendon rupture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Tibia fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Toxicity to various agents
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Myocarditis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Wrist fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood creatine phosphokinase increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Paroxysmal atrioventricular block
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood pressure increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Stress cardiomyopathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Troponin increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Ventricular arrhythmia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Alcoholic ketoacidosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Dehydration
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Diabetes with hyperosmolarity
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Fluid overload
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hyperglycaemia
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypocalcaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypoglycaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypokalaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hyponatraemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Metabolic acidosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Arthralgia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Arthritis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Compartment syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Costochondritis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Congenital, familial and genetic disorders
Congenital cystic kidney disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint effusion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint instability
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.

Other adverse events

Other adverse events
Measure
AZD7442
n=3461 participants at risk
Description (Arm-group)
Placebo
n=1736 participants at risk
Description (Arm-group)
Group 1
n=234 participants at risk
Description (Arm-group)
Group 2
n=119 participants at risk
Description (Arm-group)
Group 3a
n=76 participants at risk
Description (Arm-group)
Group 3b
n=74 participants at risk
Description (Arm-group)
Musculoskeletal and connective tissue disorders
Pelvic deformity
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Heparin-induced thrombocytopenia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Congenital, familial and genetic disorders
Hypertrophic cardiomyopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Muscle tightness
0.12%
4/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.49%
17/3461 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
4/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
0.32%
11/3461 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Myalgia
5.3%
185/3461 • Number of events 207 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.2%
90/1736 • Number of events 102 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
12.0%
28/234 • Number of events 34 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
16.8%
20/119 • Number of events 25 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
7.9%
6/76 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Myositis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Neck pain
0.35%
12/3461 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.69%
12/1736 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Osteoarthritis
1.0%
35/3461 • Number of events 37 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.2%
20/1736 • Number of events 21 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.0%
7/234 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Congenital, familial and genetic disorders
Thalassaemia beta
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Osteolysis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Osteopenia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Osteoporosis
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Pain in extremity
1.3%
45/3461 • Number of events 49 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
25/1736 • Number of events 27 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.1%
5/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Patellofemoral pain syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Pathological fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Periarthritis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Congenital, familial and genetic disorders
Type v hyperlipidaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Plantar fasciitis
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Polyarthritis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
0.20%
7/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Sacroiliitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Scapholunate dissociation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Scoliosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Cerumen impaction
0.17%
6/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Sjogren's syndrome
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Soft tissue mass
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Lupus nephritis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.29%
10/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Spinal pain
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Spinal stenosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Spondylitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Spondylolisthesis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Synovial cyst
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Synovitis
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Deafness
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Tendon calcification
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Tendon disorder
0.06%
2/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Tendon pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Tendonitis
0.17%
6/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Tenosynovitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Trigger finger
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Trismus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Vertebral foraminal stenosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Abdominal wall neoplasm
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Deafness bilateral
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.1%
5/234 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign breast neoplasm
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign hepatic neoplasm
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of skin
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign salivary gland neoplasm
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Blepharal papilloma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer fatigue
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Deafness unilateral
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon adenoma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Essential thrombocythaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Ear canal erythema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Eyelid tumour
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of bone
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hair follicle tumour benign
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hypergammaglobulinaemia benign monoclonal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Ear congestion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lipoma
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung carcinoma cell type unspecified recurrent
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
0.12%
4/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Ear discomfort
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of eyelid
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to lymph nodes
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic squamous cell carcinoma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myeloproliferative neoplasm
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Hilar lymphadenopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Ear pain
0.38%
13/3461 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Naevus haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nasal cavity cancer
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm skin
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Parathyroid tumour benign
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma recurrent
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Eustachian tube dysfunction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.03%
1/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Spinal cord neoplasm
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Excessive cerumen production
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tongue neoplasm benign
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Ageusia
1.8%
63/3461 • Number of events 67 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.0%
35/1736 • Number of events 37 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
8/234 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.2%
5/119 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.1%
3/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Altered state of consciousness
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
External ear inflammation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Amnesia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Amyotrophic lateral sclerosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Anosmia
1.6%
57/3461 • Number of events 60 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
30/1736 • Number of events 31 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.0%
7/234 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.2%
5/119 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Aphasia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Ataxia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Axonal neuropathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Balance disorder
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Bell's palsy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Burning sensation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Carotid arteriosclerosis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Haematotympanum
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Carotid artery occlusion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Carotid artery stenosis
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Carotid artery thrombosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Carpal tunnel syndrome
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Central pain syndrome
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebellar infarction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral arteriosclerosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral artery occlusion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral atrophy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Hypoacusis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral congestion
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral infarction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral ischaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral microangiopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebral small vessel ischaemic disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cerebrovascular accident
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cervical radiculopathy
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cervicobrachial syndrome
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cervicogenic headache
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Clonus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cluster headache
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cognitive disorder
0.09%
3/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Complex regional pain syndrome
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cranial nerve disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Cubital tunnel syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Dementia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Inner ear inflammation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Depressed level of consciousness
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Diabetic neuropathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Dizziness
1.5%
52/3461 • Number of events 56 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
22/1736 • Number of events 28 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.1%
5/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.1%
3/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Dizziness postural
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Dysarthria
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Dysgeusia
0.09%
3/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Encephalopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Essential tremor
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Facial paresis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Middle ear effusion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Fine motor skill dysfunction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Generalised tonic-clonic seizure
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Head discomfort
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Headache
12.7%
439/3461 • Number of events 564 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
12.2%
211/1736 • Number of events 252 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
22.2%
52/234 • Number of events 64 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
27.7%
33/119 • Number of events 42 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
9.2%
7/76 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
10.8%
8/74 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Hemiparesis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Hypersomnia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Hypoaesthesia
0.38%
13/3461 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Otorrhoea
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Hypogeusia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Hyposmia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Intercostal neuralgia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Intraneural cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Lacunar infarction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Lethargy
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Leukoencephalopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Loss of consciousness
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Hyperleukocytosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Presbyacusis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Lumbar radiculopathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Memory impairment
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Mental impairment
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Metabolic encephalopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Migraine
0.69%
24/3461 • Number of events 27 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Migraine with aura
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Movement disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Muscle contractions involuntary
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Myelopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Myoclonus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Sudden hearing loss
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Nerve compression
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Neuralgia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Neuropathy peripheral
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Normal pressure hydrocephalus
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Ophthalmic migraine
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Osmotic demyelination syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Paraesthesia
0.49%
17/3461 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Parkinson's disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Parosmia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Peripheral nerve lesion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Superior semicircular canal dehiscence
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Peroneal nerve palsy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Piriformis syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Polyneuropathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Post herpetic neuralgia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Post-traumatic headache
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Presyncope
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Psychomotor hyperactivity
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Radicular pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Radiculopathy
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Restless legs syndrome
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Tinnitus
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Sciatica
0.46%
16/3461 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Seizure
0.14%
5/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Sinus headache
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Somnolence
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Speech disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Spinal claudication
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Syncope
0.46%
16/3461 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Taste disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Tympanic membrane perforation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Tension headache
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Transient global amnesia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Transient ischaemic attack
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Tremor
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Trigeminal neuralgia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Nervous system disorders
Vascular dementia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Vertigo
0.49%
17/3461 • Number of events 20 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Product Issues
Device breakage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Product Issues
Device loosening
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Product Issues
Device malfunction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Product Issues
Device occlusion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Product Issues
Device physical property issue
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Abnormal dreams
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Acute stress disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Aggression
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Agitation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Ear and labyrinth disorders
Vertigo positional
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Alcohol abuse
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Alcoholism
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Anger
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Anxiety
0.98%
34/3461 • Number of events 36 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.63%
11/1736 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Anxiety disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Attention deficit hyperactivity disorder
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Autism spectrum disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Bipolar disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Borderline personality disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Claustrophobia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Addison's disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Confusional state
0.43%
15/3461 • Number of events 15 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
4/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Depressed mood
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Depression
0.64%
22/3461 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.1%
3/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Disorientation
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Drug abuse
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Drug use disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Euphoric mood
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Generalised anxiety disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Grief reaction
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Hallucination
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Adrenomegaly
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Hallucinations, mixed
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Insomnia
0.61%
21/3461 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.81%
14/1736 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Irritability
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Mania
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Mental status changes
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Mixed anxiety and depressive disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Nervousness
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Nightmare
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Obsessive-compulsive disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Androgen deficiency
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Panic disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Persistent complex bereavement disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Post-traumatic stress disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Rapid eye movement sleep behaviour disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Restlessness
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Sleep disorder
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Sleep terror
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Somatic symptom disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Stress
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Hypochromic anaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Autoimmune thyroiditis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Psychiatric disorders
Suicidal ideation
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Acute kidney injury
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Bladder cyst
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Bladder outlet obstruction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Bladder spasm
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Calculus bladder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Chromaturia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Chronic kidney disease
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Crystalluria
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Dysuria
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Goitre
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
End stage renal disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Glycosuria
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Haematuria
0.64%
22/3461 • Number of events 23 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Haemorrhage urinary tract
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Hydronephrosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Hypertonic bladder
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Leukocyturia
0.12%
4/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Microalbuminuria
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Micturition disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Hyperparathyroidism
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Micturition urgency
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Nephrolithiasis
0.38%
13/3461 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Nocturia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Pollakiuria
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Proteinuria
0.17%
6/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Renal colic
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Renal cyst
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Renal failure
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Renal impairment
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Hyperthyroidism
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Stag horn calculus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Stress urinary incontinence
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Ureterolithiasis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Urethral meatus stenosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Urethral stenosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Urge incontinence
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Urinary incontinence
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Urinary retention
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Renal and urinary disorders
Urinary tract obstruction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Hypogonadism
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal plaque
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Abnormal uterine bleeding
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Adenomyosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Atrophic vulvovaginitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Balanoposthitis
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Bartholin's cyst
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Breast calcifications
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Breast cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Breast enlargement
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Breast mass
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Hypothalamo-pituitary disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Breast pain
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Breast swelling
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Cervical dysplasia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Cervix inflammation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Dysmenorrhoea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Ejaculation failure
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Endometrial hyperplasia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Epididymal cyst
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Erectile dysfunction
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Fibrocystic breast disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Hypothyroidism
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Gynaecomastia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Heavy menstrual bleeding
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Intermenstrual bleeding
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Menometrorrhagia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Menopausal disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Menopausal symptoms
0.09%
3/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Menstruation irregular
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Nipple pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Oligomenorrhoea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Ovarian cyst
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Pituitary cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Pelvic adhesions
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Pelvic congestion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Pelvic pain
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Perineal pain
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Peyronie's disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Polycystic ovaries
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Postmenopausal haemorrhage
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Premenstrual syndrome
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Priapism
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Prostatitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Primary hypogonadism
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Prostatomegaly
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Testicular cyst
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Testicular pain
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Urogenital atrophy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Uterine polyp
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Uterine prolapse
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Vaginal cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Vaginal haemorrhage
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Vaginal prolapse
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Varicocele
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Thyroid atrophy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Vulva cyst
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Vulvovaginal inflammation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Vulvovaginal pain
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Reproductive system and breast disorders
Vulvovaginal pruritus
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Allergic bronchitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Asthma
0.55%
19/3461 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Increased tendency to bruise
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Endocrine disorders
Thyroid mass
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Atelectasis
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Bronchiectasis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Catarrh
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Choking
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Orthopnoea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.55%
19/3461 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
4/234 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Cough
12.2%
423/3461 • Number of events 517 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
10.3%
179/1736 • Number of events 213 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
29.1%
68/234 • Number of events 88 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
30.3%
36/119 • Number of events 58 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
18.4%
14/76 • Number of events 21 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
13.5%
10/74 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Dry throat
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Dysphonia
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
4.7%
162/3461 • Number of events 225 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.9%
67/1736 • Number of events 92 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
11.1%
26/234 • Number of events 43 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
15.1%
18/119 • Number of events 29 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.6%
5/76 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.4%
4/74 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
0.29%
10/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Emphysema
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.20%
7/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Hiccups
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Age-related macular degeneration
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Laryngeal leukoplakia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Laryngitis allergic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Lower respiratory tract congestion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Lung consolidation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Lung disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal cavity mass
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
8.2%
283/3461 • Number of events 320 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.6%
114/1736 • Number of events 128 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
17.9%
42/234 • Number of events 52 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
21.8%
26/119 • Number of events 34 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
14.5%
11/76 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
10.8%
8/74 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Asthenopia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal oedema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal pruritus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal turbinate hypertrophy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
8.8%
305/3461 • Number of events 357 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.7%
117/1736 • Number of events 135 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
20.1%
47/234 • Number of events 56 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
17.6%
21/119 • Number of events 34 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
11.8%
9/76 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
9.5%
7/74 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Astigmatism
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Peripheral arterial occlusive disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pharyngeal hypertrophy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pleural effusion
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pleurisy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Blepharitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Productive cough
0.55%
19/3461 • Number of events 19 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pulmonary artery dilatation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
0.72%
25/3461 • Number of events 26 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pulmonary fibrosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Cataract
0.32%
11/3461 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Pulmonary toxicity
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Rales
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Reflux laryngitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Respiratory distress
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Respiratory gas exchange disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.29%
10/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Chalazion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
9.1%
316/3461 • Number of events 363 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
7.1%
124/1736 • Number of events 141 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
18.4%
43/234 • Number of events 54 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
24.4%
29/119 • Number of events 40 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
10.5%
8/76 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
8.1%
6/74 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Rhonchi
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Sinonasal obstruction
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Sinus congestion
1.1%
38/3461 • Number of events 45 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.86%
15/1736 • Number of events 20 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Sinus pain
0.09%
3/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Sneezing
0.61%
21/3461 • Number of events 24 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.63%
11/1736 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Suffocation feeling
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Tachypnoea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Conjunctival haemorrhage
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Throat irritation
0.14%
5/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Throat tightness
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Tonsillar erythema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Tracheal disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Vasomotor rhinitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Vocal cord polyp
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.43%
15/3461 • Number of events 16 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Conjunctival hyperaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Acne
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Actinic keratosis
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
4/119 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Alopecia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Angioedema
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Blister
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Cold sweat
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Decubitus ulcer
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Dermal cyst
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Dermatitis
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Dermatitis acneiform
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Conjunctivitis allergic
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Dermatitis atopic
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Dermatitis contact
0.29%
10/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Diabetic wound
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Drug eruption
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Dry skin
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Ecchymosis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Eczema
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Erythema
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Dacryostenosis acquired
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Granuloma annulare
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Hand dermatitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Hidradenitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Hirsutism
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Hyperhidrosis
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Hyperkeratosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Hyperkeratosis follicularis et parafollicularis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Ingrowing nail
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Intertrigo
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Lichen sclerosus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Dermatochalasis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Lipodystrophy acquired
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Macule
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Miliaria
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Night sweats
0.32%
11/3461 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Pain of skin
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Penile ulceration
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Petechiae
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Photodermatosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Photosensitivity reaction
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Pigmentation disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Diabetic retinal oedema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Pityriasis rosea
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Pruritus
0.61%
21/3461 • Number of events 21 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.75%
13/1736 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Pruritus allergic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Psoriasis
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Purpura
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Purpura senile
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Rash
1.2%
41/3461 • Number of events 46 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
22/1736 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Rash erythematous
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Rash macular
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Diabetic retinopathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Rash papular
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Rash pruritic
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Rosacea
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Sensitive skin
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Skin lesion
0.12%
4/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Skin oedema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Skin plaque
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Skin striae
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Dry age-related macular degeneration
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Skin ulcer
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Skin and subcutaneous tissue disorders
Urticaria
0.32%
11/3461 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Social circumstances
Alcohol use
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Social circumstances
Menopause
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Social circumstances
Physical abuse
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Social circumstances
Physical assault
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Large intestinal ulcer
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Angiodysplasia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Aortic aneurysm
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Dry eye
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Aortic arteriosclerosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Aortic dilatation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Aortic stenosis
0.06%
2/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Arteriosclerosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Arteriovenous fistula
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Blood pressure fluctuation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Blood pressure inadequately controlled
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Circulatory collapse
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Deep vein thrombosis
0.23%
8/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Essential hypertension
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Erythema of eyelid
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Flushing
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Haematoma
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hot flush
0.29%
10/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hypertension
2.9%
99/3461 • Number of events 102 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.2%
56/1736 • Number of events 60 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.1%
12/234 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.9%
7/119 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
10.5%
8/76 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
8.1%
6/74 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hypertensive crisis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hypertensive emergency
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hypertensive urgency
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Hypotension
0.29%
10/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Intermittent claudication
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Lymphoedema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Eye allergy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Neurogenic shock
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Orthostatic hypotension
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Peripheral venous disease
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Phlebitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Raynaud's phenomenon
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Shock haemorrhagic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Subclavian vein thrombosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Thrombophlebitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Eye inflammation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Thrombophlebitis superficial
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Thrombosis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Varicose vein
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Vascular pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Venous thrombosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
Venous thrombosis limb
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Vascular disorders
White coat hypertension
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Leukocytosis
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Eye irritation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Eye pain
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Eye pruritus
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Eye swelling
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Glaucoma
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Keratitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Lacrimation increased
0.14%
5/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Macular degeneration
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Macular fibrosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Macular oedema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Leukopenia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Myopia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Ocular hyperaemia
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Ocular hypertension
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Ophthalmoplegia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Orbital oedema
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Periorbital oedema
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Periorbital pain
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Periorbital swelling
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Photophobia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Posterior capsule opacification
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Lymph node pain
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Presbyopia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Pterygium
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Retinal detachment
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Retinal tear
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Scleritis
0.06%
2/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Swelling of eyelid
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Uveitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Vision blurred
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Visual field defect
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Visual impairment
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Lymphadenitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Vitreous adhesions
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Vitreous detachment
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Eye disorders
Vitreous floaters
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal discomfort
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal distension
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal hernia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal mass
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal pain
0.84%
29/3461 • Number of events 30 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.1%
19/1736 • Number of events 21 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.0%
7/234 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
4/119 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal pain lower
0.32%
11/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal pain upper
0.61%
21/3461 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Anaemia
1.1%
37/3461 • Number of events 37 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.98%
17/1736 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Lymphadenopathy
0.43%
15/3461 • Number of events 18 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal rigidity
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Abdominal tenderness
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Anal fissure
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Anal fistula
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Anal polyp
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Anal pruritus
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Anal skin tags
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Angular cheilitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Anogenital dysplasia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Anorectal disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Lymphadenopathy mediastinal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Aphthous ulcer
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Apical granuloma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Ascites
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Bile acid malabsorption
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Bowel movement irregularity
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Change of bowel habit
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Cheilitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Chronic gastritis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Coeliac disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Colitis
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Lymphopenia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Colitis microscopic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Colitis ulcerative
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Constipation
0.72%
25/3461 • Number of events 26 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.63%
11/1736 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.1%
5/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Crohn's disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Dental caries
0.14%
5/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Diaphragmatic hernia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Diarrhoea
5.3%
183/3461 • Number of events 206 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.7%
81/1736 • Number of events 91 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
9.8%
23/234 • Number of events 26 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
13.4%
16/119 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.6%
5/76 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.1%
3/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Diverticulum
0.32%
11/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Diverticulum intestinal
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Macrocytosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Dry mouth
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Duodenal ulcer
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Duodenitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Dyskinesia oesophageal
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Dyspepsia
0.38%
13/3461 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Dysphagia
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Eosinophilic oesophagitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Eructation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Faeces discoloured
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Microcytic anaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Faeces soft
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Flatulence
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Food poisoning
0.09%
3/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Frequent bowel movements
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Functional gastrointestinal disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastric disorder
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastric ulcer
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastritis
0.29%
10/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.3%
4/76 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastritis alcoholic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Neutropenia
0.14%
5/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastritis erosive
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastrointestinal disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastrointestinal hypermotility
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastrointestinal motility disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastrointestinal mucosa hyperaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastrointestinal pain
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gastrooesophageal reflux disease
0.81%
28/3461 • Number of events 28 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.81%
14/1736 • Number of events 15 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.1%
5/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.2%
5/119 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Giant cell epulis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Neutrophilia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gingival bleeding
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gingival disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Gingival pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Glossitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Glossodynia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Haematemesis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Haematochezia
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Haemorrhoids
0.43%
15/3461 • Number of events 15 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Haemorrhoids thrombosed
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Hiatus hernia
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Normochromic normocytic anaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Hyperaesthesia teeth
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Hypoaesthesia oral
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Ileus
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Impaired gastric emptying
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Inflammatory bowel disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Inguinal hernia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Inguinal hernia strangulated
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Normocytic anaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Irritable bowel syndrome
0.20%
7/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Large intestinal stenosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Large intestine polyp
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Lip disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Loose tooth
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Melaena
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Mouth haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Pancytopenia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Mouth ulceration
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Nausea
4.7%
163/3461 • Number of events 191 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.3%
75/1736 • Number of events 82 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.0%
14/234 • Number of events 16 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.7%
8/119 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
10.5%
8/76 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
8.1%
6/74 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Odynophagia
0.12%
4/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oesophageal dilatation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oesophageal disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oesophageal motility disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oesophageal spasm
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oesophageal stenosis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oesophagitis
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Anaemia of chronic disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Polycythaemia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oral disorder
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oral mucosal blistering
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oral mucosal eruption
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Oral pain
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Pancreatic failure
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Pancreatic mass
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Pancreatic steatosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Pancreatitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Splenomegaly
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Pancreatitis chronic
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Paraesthesia oral
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Peptic ulcer
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Periodontal disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Plicated tongue
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Proctitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Rectal haemorrhage
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Thrombocytopenia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Rectal polyp
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Salivary gland disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Salivary gland enlargement
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Allergy to arthropod bite
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Salivary gland mucocoele
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Salivary hypersecretion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Sigmoid mesocolon hernia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Small intestinal obstruction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Submaxillary gland enlargement
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Swollen tongue
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Thrombocytosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Tongue discolouration
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Tongue discomfort
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Tongue disorder
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Tongue erythema
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Tongue geographic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Tongue ulceration
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Tooth disorder
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Tooth impacted
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Tooth loss
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Toothache
0.49%
17/3461 • Number of events 18 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Acute coronary syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Trichoglossia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Umbilical hernia
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Uvulitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Gastrointestinal disorders
Vomiting
1.7%
60/3461 • Number of events 75 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
30/1736 • Number of events 33 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.3%
10/234 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.1%
3/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Adverse drug reaction
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Asthenia
0.55%
19/3461 • Number of events 20 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.81%
14/1736 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Axillary pain
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Catheter site swelling
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Acute left ventricular failure
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Chest discomfort
0.26%
9/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Chest pain
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Chills
4.5%
155/3461 • Number of events 169 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.1%
72/1736 • Number of events 79 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
9.0%
21/234 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
14.3%
17/119 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
7.9%
6/76 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.8%
5/74 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Chronic fatigue syndrome
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Crepitations
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Cyst
0.09%
3/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Drug withdrawal syndrome
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Energy increased
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Facial discomfort
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Acute myocardial infarction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Facial pain
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Fatigue
10.7%
369/3461 • Number of events 439 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
9.6%
166/1736 • Number of events 201 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
23.1%
54/234 • Number of events 68 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
27.7%
33/119 • Number of events 49 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
14.5%
11/76 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
8.1%
6/74 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Feeling abnormal
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Feeling cold
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Feeling hot
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Feeling jittery
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Foaming at mouth
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Gait disturbance
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Generalised oedema
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Hangover
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Angina pectoris
0.29%
10/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Hernia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Inflammation
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Influenza like illness
0.78%
27/3461 • Number of events 29 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.81%
14/1736 • Number of events 16 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
4/119 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site bruising
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site discomfort
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site erythema
0.23%
8/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site haematoma
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site haemorrhage
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site induration
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site joint pain
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Angina unstable
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site mass
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site oedema
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site pain
1.1%
37/3461 • Number of events 39 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.1%
19/1736 • Number of events 20 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.3%
4/76 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site paraesthesia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site pruritus
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site rash
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site reaction
0.17%
6/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site swelling
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site urticaria
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injection site warmth
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Aortic valve sclerosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Injury associated with device
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Malaise
1.3%
46/3461 • Number of events 46 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
8/234 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
4/119 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Mass
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Medical device site irritation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Non-cardiac chest pain
0.40%
14/3461 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Oedema
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Oedema peripheral
0.49%
17/3461 • Number of events 18 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Pain
5.3%
185/3461 • Number of events 212 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.6%
79/1736 • Number of events 82 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
10.7%
25/234 • Number of events 30 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
16.0%
19/119 • Number of events 20 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
10.5%
8/76 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.8%
5/74 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Peripheral swelling
0.43%
15/3461 • Number of events 16 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Blood loss anaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Aortic valve stenosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Puncture site oedema
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Puncture site pruritus
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Pyrexia
4.3%
150/3461 • Number of events 158 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.4%
77/1736 • Number of events 84 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
9.8%
23/234 • Number of events 28 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
12.6%
15/119 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
7.9%
6/76 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.8%
5/74 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Retention cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Secretion discharge
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Sensation of foreign body
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Swelling
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Swelling face
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Systemic inflammatory response syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Vaccination site discomfort
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Arrhythmia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Vaccination site erythema
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Vaccination site mass
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Vaccination site pain
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Vaccination site reaction
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Vessel puncture site bruise
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Vessel puncture site haematoma
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
General disorders
Vessel puncture site haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Bile duct stone
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Biliary colic
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Biliary dyskinesia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Arrhythmia supraventricular
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Biliary obstruction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Cholecystitis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Cholecystitis chronic
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Cholelithiasis
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatic cirrhosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatic cyst
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatic cytolysis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Arteriosclerosis coronary artery
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatic fibrosis
0.06%
2/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatic steatosis
0.32%
11/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatobiliary cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hepatosplenomegaly
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Hyperplastic cholecystopathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Non-alcoholic steatohepatitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Nonalcoholic fatty liver disease
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Hepatobiliary disorders
Portal vein thrombosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Allergy to arthropod sting
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Atrial enlargement
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Allergy to chemicals
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Allergy to plants
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Anaphylactic reaction
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Drug hypersensitivity
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Food allergy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Hypersensitivity
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Hypogammaglobulinaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Mite allergy
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Atrial fibrillation
0.38%
13/3461 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.9%
3/76 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Primary amyloidosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Sarcoidosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumonia
0.61%
21/3461 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Immune system disorders
Seasonal allergy
0.84%
29/3461 • Number of events 29 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.63%
11/1736 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
4/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Abdominal abscess
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Abscess limb
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Acarodermatitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Acute sinusitis
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Anal candidiasis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Anal chlamydia infection
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Appendicitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Atrial flutter
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Arteriovenous graft site infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Arthritis bacterial
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Asymptomatic covid-19
0.81%
28/3461 • Number of events 28 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.98%
17/1736 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.8%
9/234 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.9%
7/119 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.9%
3/76 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Asymptomatic bacteriuria
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Atypical pneumonia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Bacteraemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Bacterial disease carrier
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Bacterial infection
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Bacterial vaginosis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Bacteriuria
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Balanitis candida
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Beta haemolytic streptococcal infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Body tinea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Bronchitis
0.92%
32/3461 • Number of events 35 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Bronchitis bacterial
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Covid-19
13.4%
465/3461 • Number of events 475 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
13.2%
229/1736 • Number of events 240 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
27.4%
64/234 • Number of events 69 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
29.4%
35/119 • Number of events 39 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
17.1%
13/76 • Number of events 15 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
16.2%
12/74 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Covid-19 pneumonia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Campylobacter gastroenteritis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Atrioventricular block first degree
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Candida infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Cellulitis
0.40%
14/3461 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Cervicitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Chlamydial infection
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Chronic sinusitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Coccidioidomycosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Conjunctivitis
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Conjunctivitis bacterial
0.06%
2/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Cystitis
0.55%
19/3461 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Cystitis escherichia
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Cytomegalovirus infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Dacryocanaliculitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Dengue haemorrhagic fever
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Dermatophytosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Device related infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Diarrhoea infectious
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Diverticulitis
0.26%
9/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Ear infection
0.40%
14/3461 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Bone marrow oedema
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Bifascicular block
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Enterobiasis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Epididymitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Erysipelas
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Escherichia infection
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Escherichia urinary tract infection
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Eye abscess
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Eye infection
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Bradycardia
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Febrile infection
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Folliculitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Fungaemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Fungal infection
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Fungal skin infection
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Furuncle
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gastroenteritis
0.61%
21/3461 • Number of events 21 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gastroenteritis viral
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gastrointestinal bacterial overgrowth
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Bundle branch block left
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gastrointestinal infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gastrointestinal viral infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Genital herpes
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Genitourinary chlamydia infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gingival abscess
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gingivitis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gonococcal infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Gonorrhoea
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Groin infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Hiv peripheral neuropathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Bundle branch block right
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Haemophilus infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Helicobacter infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Hepatitis c
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Herpes simplex
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Herpes simplex reactivation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Herpes zoster
0.46%
16/3461 • Number of events 16 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
4/234 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Hordeolum
0.23%
8/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Impetigo
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Infected bite
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Infected cyst
0.09%
3/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Infected dermal cyst
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Infected skin ulcer
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Infectious mononucleosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Infectious pleural effusion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Infective exacerbation of bronchiectasis
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Infective exacerbation of chronic obstructive airways disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Influenza
0.35%
12/3461 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.9%
3/76 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiac failure
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Intervertebral discitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Kidney infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Klebsiella infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Labyrinthitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Laryngitis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Localised infection
0.14%
5/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Lower respiratory tract infection
0.78%
27/3461 • Number of events 30 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.2%
20/1736 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.0%
7/234 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Lower respiratory tract infection bacterial
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Lower respiratory tract infection viral
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Lung abscess
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiac failure acute
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Lyme disease
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Lymphangitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Mastitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Mastoiditis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Medical device site abscess
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Molluscum contagiosum
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Mucormycosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Nail bed infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Nasal vestibulitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiac failure congestive
0.06%
2/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Nasopharyngitis
1.2%
42/3461 • Number of events 47 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.5%
26/1736 • Number of events 26 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.1%
12/234 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
4/119 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Norovirus infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Onychomycosis
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Oral candidiasis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Oral fungal infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Oral herpes
0.40%
14/3461 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Oral infection
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Orchitis
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Oropharyngeal candidiasis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Oropharyngeal gonococcal infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Osteomyelitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Otitis externa
0.23%
8/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Otitis media
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Otitis media acute
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Papilloma viral infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Paronychia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Parotitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pelvic inflammatory disease
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Perichondritis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Periodontitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Peritonsillar abscess
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pertussis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pharyngitis
0.49%
17/3461 • Number of events 18 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.69%
12/1736 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pharyngitis bacterial
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pharyngitis streptococcal
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pilonidal cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Coagulopathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiomegaly
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumonia bacterial
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumonia klebsiella
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pneumonia viral
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Post procedural infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Post procedural pneumonia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Post-acute covid-19 syndrome
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Postoperative wound infection
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Proctitis gonococcal
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Cardiomyopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pustule
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pyelonephritis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pyelonephritis acute
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Pyuria
0.26%
9/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Respiratory syncytial virus infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Respiratory tract chlamydial infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Respiratory tract infection
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Respiratory tract infection viral
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Rhinitis
0.98%
34/3461 • Number of events 37 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.86%
15/1736 • Number of events 18 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Chronotropic incompetence
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Root canal infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Secondary syphilis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Sepsis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Sialoadenitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Sinusitis
0.98%
34/3461 • Number of events 39 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.1%
19/1736 • Number of events 23 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
8/234 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Sinusitis bacterial
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Sinusitis fungal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Skin bacterial infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Skin infection
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Coronary artery disease
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Spirochaetal infection
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Staphylococcal abscess
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Staphylococcal infection
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Staphylococcal skin infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Subcutaneous abscess
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Suspected covid-19
0.12%
4/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Syphilis
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Systemic candida
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Tinea cruris
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Coronary artery occlusion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Tinea infection
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Tinea pedis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Tinea versicolour
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Tonsillitis
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Tooth abscess
0.40%
14/3461 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Tooth infection
0.43%
15/3461 • Number of events 15 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Trichomoniasis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Upper respiratory tract infection
1.6%
54/3461 • Number of events 59 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.0%
34/1736 • Number of events 44 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
8/234 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.7%
8/119 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Upper respiratory tract infection bacterial
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Urethritis gonococcal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Coronary artery stenosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Urinary tract infection
3.5%
122/3461 • Number of events 146 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.4%
59/1736 • Number of events 63 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.6%
13/234 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
8.4%
10/119 • Number of events 16 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
7.9%
6/76 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
8.1%
6/74 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Urinary tract infection bacterial
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Post procedural complication
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Urinary tract infection staphylococcal
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Vaginal cellulitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Vaginal infection
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Viraemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Viral diarrhoea
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Viral infection
0.61%
21/3461 • Number of events 23 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.69%
12/1736 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Diastolic dysfunction
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Viral pharyngitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Viral rhinitis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Viral upper respiratory tract infection
0.43%
15/3461 • Number of events 15 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Vulvovaginal candidiasis
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Vulvovaginal mycotic infection
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Infections and infestations
Wound infection
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Abdominal injury
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Accident
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Accident at work
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Extrasystoles
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Alcohol poisoning
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Anaesthetic complication
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Animal bite
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Ankle fracture
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Arteriovenous fistula aneurysm
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Arteriovenous fistula occlusion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Arteriovenous fistula site haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Arthropod bite
0.26%
9/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Arthropod sting
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Intracardiac thrombus
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Avulsion fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Back injury
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Barotitis media
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Bone contusion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Cartilage injury
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Chemical burns of eye
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Chest injury
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Clavicle fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Complications of transplant surgery
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Ischaemic cardiomyopathy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Concussion
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Contusion
0.64%
22/3461 • Number of events 24 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Corneal abrasion
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Craniocerebral injury
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Epicondylitis
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Extradural haematoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Eye injury
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Eyelid contusion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Face injury
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Facial bones fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Deficiency anaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Left atrial enlargement
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Fall
1.3%
44/3461 • Number of events 44 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.98%
17/1736 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.8%
9/234 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.9%
7/119 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Femur fracture
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Fibula fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Foot fracture
0.43%
15/3461 • Number of events 15 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Forearm fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Foreign body
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Foreign body in ear
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Foreign body in eye
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Graft complication
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Left ventricular dysfunction
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Gun shot wound
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Haemodialysis complication
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Hand fracture
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Head injury
0.29%
10/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Heat exhaustion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Hip fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Humerus fracture
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Hyphaema
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Incisional hernia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Left ventricular failure
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Injection related reaction
0.29%
10/3461 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Injury
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Joint dislocation
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Joint injury
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Ligament injury
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Ligament rupture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Ligament sprain
0.52%
18/3461 • Number of events 18 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.35%
6/1736 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Limb injury
0.32%
11/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Lip injury
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Lower limb fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Left ventricular hypertrophy
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Lumbar vertebral fracture
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Median nerve injury
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Meniscus injury
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Multiple fractures
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Muscle injury
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Muscle rupture
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Muscle strain
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Neck injury
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Nerve injury
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Osteochondral fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Overdose
0.03%
1/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Patella fracture
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Pelvic bone injury
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Periorbital haematoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Poisoning
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Post concussion syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Post procedural constipation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Mitral valve incompetence
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Post procedural diarrhoea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Post-traumatic pain
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Postoperative delirium
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Procedural nausea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Procedural pain
0.29%
10/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Radiation pneumonitis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Radius fracture
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Rib fracture
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Road traffic accident
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Mitral valve stenosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Second degree chemical burn of skin
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Seroma
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Skin abrasion
0.23%
8/3461 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Skin injury
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Skin laceration
0.64%
22/3461 • Number of events 25 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Skin wound
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Skull fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Spinal column injury
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Transferrin saturation increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Splinter
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Stab wound
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Myocardial infarction
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Stoma site haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Stomal hernia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Stress fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Subdural haematoma
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Sunburn
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Tendon injury
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Tendon rupture
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Thermal burn
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Myocardial ischaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Thoracic vertebral fracture
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Tibia fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Tooth fracture
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Traumatic haematoma
0.06%
2/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Traumatic ulcer
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Ulnar nerve injury
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Upper limb fracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Vaccination complication
2.1%
71/3461 • Number of events 132 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.9%
50/1736 • Number of events 81 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Vascular access site haemorrhage
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Myocarditis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Vulvovaginal injury
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Wound
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Injury, poisoning and procedural complications
Wrist fracture
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Activated partial thromboplastin time prolonged
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Alanine aminotransferase abnormal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Alanine aminotransferase increased
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Anti factor viii antibody increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Aortic bruit
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Aspartate aminotransferase increased
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Bacterial test positive
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Disseminated intravascular coagulation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Palpitations
0.49%
17/3461 • Number of events 21 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.1%
5/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood hiv rna increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood alkaline phosphatase increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood bilirubin increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood calcium increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood cholesterol increased
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.1%
5/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood creatine phosphokinase increased
0.69%
24/3461 • Number of events 24 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.98%
17/1736 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood creatinine increased
0.14%
5/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood folate decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood glucose abnormal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood glucose fluctuation
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood glucose increased
0.49%
17/3461 • Number of events 17 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood iron decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood magnesium decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood potassium decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood potassium increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood pressure diastolic increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood pressure increased
0.46%
16/3461 • Number of events 16 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood pressure systolic increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood sodium increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood testosterone decreased
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Pericardial effusion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood thrombin increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.1%
3/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood thyroid stimulating hormone decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood thyroid stimulating hormone increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood urea increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood uric acid increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Blood urine present
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Body temperature decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Body temperature increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Brain natriuretic peptide increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
C-reactive protein increased
0.46%
16/3461 • Number of events 16 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Sinus arrhythmia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Carbohydrate antigen 19-9 increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Cardiac murmur
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Chlamydia test positive
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Coagulation factor viii level increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Coagulation factor increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Coagulation test abnormal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Cortisol decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Creatinine renal clearance increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Crystal urine present
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Culture urine positive
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Sinus bradycardia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Ecg signs of ventricular hypertrophy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Electrocardiogram p wave biphasic
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Electrocardiogram qt prolonged
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Electrocardiogram t wave abnormal
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Electrocardiogram t wave amplitude decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Electrocardiogram t wave inversion
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Electrocardiogram abnormal
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Electrocardiogram repolarisation abnormality
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Fibrin d dimer increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.4%
4/74 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Gamma-glutamyltransferase abnormal
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Sinus tachycardia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Gamma-glutamyltransferase increased
0.35%
12/3461 • Number of events 12 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Glomerular filtration rate decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Glucose urine present
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Glycosylated haemoglobin increased
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Hiv test positive
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Haematocrit increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Haemoglobin decreased
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Heart rate increased
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Hepatic enzyme increased
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
International normalised ratio abnormal
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
International normalised ratio increased
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Laboratory test abnormal
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Lipase increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Lipids increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Liver function test abnormal
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Liver function test increased
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Low density lipoprotein increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Mean cell volume decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Monocyte count increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Mycoplasma test positive
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Supraventricular extrasystoles
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
N-terminal prohormone brain natriuretic peptide increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Neisseria test positive
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Neutrophil count decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Neutrophil count increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Norovirus test positive
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Oxygen saturation decreased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Platelet count decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Platelet count increased
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Prostatic specific antigen increased
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Protein urine present
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Supraventricular tachycardia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Prothrombin level increased
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Qrs axis abnormal
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Red blood cell count increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Red blood cells urine positive
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Respiratory rate decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Respiratory rate increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Reticulocyte count decreased
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Reticulocyte count increased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Sars-cov-2 test positive
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Serum ferritin decreased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Tachycardia
0.32%
11/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Smear cervix abnormal
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Streptococcus test positive
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Thrombin-antithrombin iii complex increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Transaminases increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Troponin i increased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Troponin increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Urinary casts
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Urine analysis abnormal
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.23%
4/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Urine output decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Blood and lymphatic system disorders
Febrile neutropenia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Vitamin b1 decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Vitamin b12 decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Vitamin d decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Weight decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
Weight increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
White blood cell count decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
White blood cell count increased
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
White blood cells urine
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Investigations
White blood cells urine positive
0.29%
10/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.29%
5/1736 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Ventricular extrasystoles
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Calciphylaxis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Decreased appetite
1.9%
67/3461 • Number of events 75 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
30/1736 • Number of events 35 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.0%
14/234 • Number of events 14 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
7.6%
9/119 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.1%
3/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Dehydration
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Diabetes mellitus
0.32%
11/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
5.3%
4/76 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Dyslipidaemia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Fluid overload
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Folate deficiency
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Ventricular fibrillation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Glucose tolerance impaired
0.23%
8/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Gout
0.38%
13/3461 • Number of events 13 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Histamine intolerance
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypercalcaemia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypercholesterolaemia
0.52%
18/3461 • Number of events 18 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.2%
5/119 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hyperglycaemia
0.69%
24/3461 • Number of events 24 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hyperkalaemia
0.17%
6/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hyperlipidaemia
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypernatraemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hyperphosphataemia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Ventricular hypertrophy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypertriglyceridaemia
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypocalcaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypoglycaemia
0.12%
4/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypokalaemia
0.26%
9/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
4/234 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypomagnesaemia
0.09%
3/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
3/234 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hyponatraemia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypophagia
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypophosphataemia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypovitaminosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Hypovolaemia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Ventricular hypokinesia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Increased appetite
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Iron deficiency
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Lactic acidosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Malnutrition
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Metabolic acidosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Metabolic syndrome
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Obesity
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.52%
18/3461 • Number of events 18 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.46%
8/1736 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.6%
2/76 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Vitamin b complex deficiency
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Vitamin b12 deficiency
0.14%
5/3461 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Cardiac disorders
Ventricular tachycardia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Metabolism and nutrition disorders
Vitamin d deficiency
0.66%
23/3461 • Number of events 24 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.58%
10/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.5%
3/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Ankle deformity
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Ankylosing spondylitis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Arthralgia
3.5%
122/3461 • Number of events 137 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.9%
51/1736 • Number of events 56 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
6.8%
16/234 • Number of events 19 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
4.2%
5/119 • Number of events 5 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.9%
3/76 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
2.7%
2/74 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Arthritis
0.26%
9/3461 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Arthropathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Back pain
2.5%
85/3461 • Number of events 90 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.1%
53/1736 • Number of events 57 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
3.8%
9/234 • Number of events 9 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Bone pain
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Bursitis
0.20%
7/3461 • Number of events 8 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.7%
2/119 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Cervical spinal stenosis
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Congenital, familial and genetic disorders
Arteriovenous malformation
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Chondromalacia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Coccydynia
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Costochondritis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Diastasis recti abdominis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Enostosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Enthesopathy
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Exostosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Exostosis of jaw
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Facet joint syndrome
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.17%
3/1736 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Femoroacetabular impingement
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Fibromyalgia
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Flank pain
0.14%
5/3461 • Number of events 6 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Foot deformity
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Groin pain
0.09%
3/3461 • Number of events 3 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Haemarthrosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Congenital, familial and genetic disorders
Dermoid cyst
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
0.12%
4/3461 • Number of events 4 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Intervertebral disc displacement
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
0.32%
11/3461 • Number of events 11 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.52%
9/1736 • Number of events 10 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint ankylosis
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint contracture
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint effusion
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint hyperextension
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint noise
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Congenital, familial and genetic disorders
Gastrointestinal arteriovenous malformation
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint stiffness
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Joint swelling
0.20%
7/3461 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.12%
2/1736 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Limb discomfort
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Limb mass
0.06%
2/3461 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Mobility decreased
0.00%
0/3461 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.43%
1/234 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Morphoea
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/1736 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Muscle atrophy
0.03%
1/3461 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.06%
1/1736 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/234 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/119 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/76 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.00%
0/74 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
Musculoskeletal and connective tissue disorders
Muscle spasms
0.64%
22/3461 • Number of events 22 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.40%
7/1736 • Number of events 7 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.85%
2/234 • Number of events 2 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
0.84%
1/119 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.3%
1/76 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.
1.4%
1/74 • Number of events 1 • All AEs were collected from the time of IMP administration throughout the study, up to and including the last visit. For the Main study the duration of follow up from Dose of IMP to End of Study (Days) was in the range of 1-605. For the Sub Study the range was 1-688 days.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60